RANJAN P. MALHOTRA, M.D., F.A.C.S.

Transcription

1 RANJAN P. MALHOTRA, M.D., F.A.C.S. Clinical Instructor of Ophthalmology Washington University School of Medicine St. Louis, Missouri Primary Office Address: Manchester Road, Suite 200 Saint Louis, Missouri Phone: Facsimile: Secondary Office Address: 965 Mattox Drive Sullivan, MO Phone: Ext. 416 Primary Surgical Address: St. Louis Eye Surgery and Laser Center Manchester Road, #103 St. Louis, MO Date of Birth: May 27, 1971 Place of Birth: St. Louis, Missouri EDUCATION: Fellowship Cornea, Refractive Surgery, and External Disease Dean McGee Eye Institute University of Oklahoma Oklahoma City, Oklahoma Residency University of Texas Southwestern Medical Center Department of Ophthalmology Parkland Memorial Hospital, Dallas, Texas Internship St. John s Mercy Medical Center Transitional Year Internship St. Louis, Missouri M.D University of Missouri at Kansas City Accelerated Combined B.A./M.D.Program B.A University of Missouri at Kansas City Bachelor of Arts in Biology with Distinction,

2 HONORS: 1999 Alumni Day Research Award, Dallas, Texas Alpha Omega Alpha, President 1995 Merck Manual Award Snake of Aesculapius Award Omicron Delta Kappa Honor Society Mortar Board Honor Society Dean s List Bright Flight of Missouri Scholarship Curators of Missouri Scholarship 1989 Dartmouth Book Award LICENSURE AND CERTIFICATION: Missouri State License 2000 to Present Oklahoma State Medical License Customvue Wavefront Certification VISX Present LASIK Certification Present PRK Certification Present Texas State Medical License DEA Registration Number 1997 to Present RESEARCH: Involved in Phase 2,3 and 4 Clinical Trials for Dry Eye, Allergy, Blepharitis, Conjunctivitis, Cataract surgery and Glaucoma (see attached list). PUBLICATIONS: Malhotra, R., Ackerman, S., Gearinger, L., Morris, T., Allaire, C.: The Safety of Besifloxacin Ophthalmoic Suspension 0.6% Used Three Times Daily for 7 Days in the Treatment of Bacterial Conjunctivitis. Springer On Line First /s Malhotra, RP. Wolf TC, Chodosh J. Diffuse Lamellar Keratitis after Traumatic Corneal Abrasion Postoperative LASIK Patients. Published in departmental publication for Dean A. McGee Eye Institute, June 10, Malhotra RP. Bowman RW. Corneal Sensation after Laser Intrastromal Keratomileusis (LASIK) Published in departmental publication for Southwestern Medical School, *Alumni Day Research Award, June Malhotra RP. Bowman RW. Retreatment after Excimer Laser Photorefractive 2

3 Keratectomy (PRK) and Laser Intrastromal Keratomileusis (LASIK) Published and presented as paper at American Society of Cataract and Refractive Surgeons, Seattle WA April Malhotra RP. Park S. The Effects of Vitrectomy and Membrane Peeling on Metmorphopsia and Visual Acuity in Patients with Macular Pucker Published in a departmental publication for Southwestern Medical School, June Malhotra RP. Jaffe. Tauber J. Contact Lens and Spectacle Use Before and After Photorefractive Keratectomy Accepted for publication and poster presentation for Contact Lens Association of Ophthalmologists Conference, Las Vegas NV, January Malhotra RP. Nyquist-Battle C. Dreyfus LA. Morris SJ. Escherichia coli Heat-stable Enterotoxin B (Stb) Opens ad G-protein Operated Calcium Channel in the Myocyte Plasma Membrane Student paper presentation at University of Missouri-Kansas City School of Medicine Research Days, April Morris SJ Chronwall B. Malhotra RP Beatty D. Simultaneous Kinetic Imaging of Intracellular Calcium and ph in Single Melanotropes Student poster presentation at University of Missouri-Kansas City School of Medicine Research Days, October PROFESSIONAL ORGANIZATIONS: Alcon Speaker s Alliance Allergan Core Speakers American Academy of Ophthalmology (AAO) American Association of Physicians of Indian Origin (AAPI) American Society of Cataract and Refractive Surgeons (ASCRS) American Medical Association (AMA) Indian Medical Council of Greater St. Louis Indian Association of St. Louis Missouri Ophthalmologic Society of Eye Physicians and Surgeons (MOSEPS) Missouri State Medial Association (MSMA) National Board of Ophthalmology St. Louis Ophthalmology Society (SLOS) LEADERSHIP AND EMPLOYMENT: Ophthalmology Associates/Cornea & Laser Vision Institute, Vice President 2000 to Present Missouri Ophthalmologic Society of Eye Physicians and 3

4 Surgeons Board of Directors, St. Louis Representative St. Louis Ophthalmology Society Present Indian Medical Council of Greater St. Louis Board Member Present Indian Association of St. Louis Board Member Denton State School for Mentally Impaired Adults, Ophthalmology clinic Alpha Omega Alpha, Chapter President Kansas City Free Health Clinic Medical Student Advisory Council Representative Clinical Research Study Participation by Ophthalmology Associates Ranjan P. Malhotra, M.D.,F.A.C.S. Gregg J. Berdy, M.D., F.A.C.S. Robert C. Brusatti, O.D. Alcon Protocol C (2000) A Comparative Study of the Prophylactic Use of Olopatadine 0.1% Ophthalmic Solution Versus Placebo, in Patients with Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis Senju - Protocol TIMLA-301-PC-1 (2001) A double-masked, randomized, parallel study of the safety and efficacy of Timolol-LA in patients with ocular hypertension or open-angle glaucoma Allergan - Protocol l (2001) A Multi-Center, Randomized, Double-Masked, Parallel Group Study Evaluating the Efficacy and Safety of Epinastine Hydrochloride 0.05% Ophthalmic Solution Compared to Vehicle of Epinastine or to Levocabastine 0.05% Ophthalmic Suspension Used Twice Daily for 8 Weeks in an Environmental Study in Adult and Pediatric Patients with seasonal Allergic Conjunctivitis Inspire - Protocol (2002) A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects with Dry eye Disease Allergan - Protocol l (2002) A Multi-Center, Parallel, Randomized, Double-Masked, Vehicle Controlled, Dose-Ranging Study to Evaluate the Safety, tolerability, and Efficacy of Testosterone 0.01T, 0.1%, and 0.3% Ophthalmic Solutions Administered Twice Daily for 16 weeks in Patients with Keratoconjunctivitis Sicca (KCS) Ciba Vision (Novartis) - Protocol P-215-C-001 Ham Comfort Drops Registration Trial Ciba Vision - Protocol 019-C-004 SEE3 Monthly Extended Wear Safety & Efficacy Study Ciba Vision - Protocol P-019-C-023 (2003) Focus Night & Day Post-approval Evaluation (contact lens study) Medennium - Protocol # Plug (2002) A Prospective, Randomized, Open-Label Clinical Evaluation of the Efficacy, Safety and Substantial Equivalence of the Medennium Inc. SmartPlug vs. the Oasis Soft Plug in the Treatment of Dry Eye 4

5 Alcon - Protocol C (2003) A Phase II, Dose-Ranging Study to Evaluate Rimexolone 0.005%, 0.05% and 01% Ophthalmic Suspensions Versus Rimexolone Vehicle in Relieving the Ocular Signs and Symptoms of Dry Eye in Patients with Autoimmune Connective Tissue Disease. Alcon - Protocol C (2003) A Comparison of CIPRODEX (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Ophthalmic Suspension, versus CILOXAN (Ciprofloxacin 0.3%) Ophthalmic Solution, MAXIDEX (Dexamethasone 0.1% ) Ophthalmic Suspension and CIPRODEX Vehicle for Treatment of Bacterial Blepharitis Allergan Protocol AG A Multi-Center, Investigator-Masked, Randomized, Parallel-Group Study to Compare the Efficacy and Safety of an Investigational Multi-Dose Emulsion eye Drop vs. Refresh Endura eye Drops for one Month (with a Two Month Masked Extension) in Subjects with Dry Eye Alcon Protocol C (2004) A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Patients with Allergic Conjunctivitis Who Were Previously Treated with Olopatadine 0.1% AstraZeneca Protocol 5077IL/0089 ( ) A multicenter, open-label, flexible-dose, parallel-group evaluation of the cataractogenic Potential of quetiapine fumarate (SEROQUEL) and risperidone (RISPERDAL) in the Long-term treatment of patients with schizophrenia or schizoaffective disorder Sucampo Protocol SPI/506OK-0221; Phase II (2004) A Prospective, Randomized, Phase II, Dose-Ranging, Double-Masked, Placebo-Controlled, Parallel-Dose, Multicenter Trial to Evaluate the Efficacy and Safety of FK506 Eye Drops in Subjects with Keratoconjunctivitis Sicca (Dry Eye) Inspire Protocol (2004) A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of diquafosol tetrasodium ophthalmic solution, 2% in Subjects with Dry Eye Disease Insite Vision Protocol C ( ) A Study to Evaluate the Clinical and Microbial Efficacy and Safety of 1.0% Azasite Compared to 0.3% Tobramycin Ophthalmic Solution in the Treatment of Bacterial Conjunctivitis Otsuka Maryland Research Institute Protocol 37E ( ) Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 26-Week Study Inspire Protocol (2005) A Multi-Center, Double-Masked, Randomized Study Evaluating Measures of Patient Preference of epinastine HCI ophthalmic solution, 0.05% (Elestat) versus olopatadine Hydrochloride ophthalmic solution, 0.1% (Patanol) in Subjects with Symptomatic Seasonal Allergic Conjunctivitis Lantibio, Inc. Moli 1901 DE 002 ( ) A Phase 2 Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Dose Ranging Study of Moli1901 Ophthalmic Solution in Subjects with Moderate to Severe Dry Eye Syndrome 5

6 Pfizer Protocol A (2006) A 12-Week, Randomized, Double-Masked, Parallel Group Comparison of Xalacom Given in the Evening, Xalatan Given in the Evening, and Timolol Given in the Morning in Subjects With Open Angle Glaucoma or Ocular Hypertension in the United States Alcon Protocol C (2006) A Double-Masked, Parallel Group, Randomized, Single-Dose Bioequivalent Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension Alcon Protocol C (2006) A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients with Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis Bausch & Lomb Protocol 434 ( ) A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vigamox in the Treatment of Bacterial Conjunctivitis Alcon Protocol C ( ) A Randomized, Double-Masked Safety and Efficacy Study of FID # Compared to FID # in the Treatment of Dry Eye Vistakon Protocol (2006) A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and Impact on Quality of Life of R % Ophthalmic Solution Compared to Vehicle or Olopatadine HCl 0.1% Ophthalmic Solution for 6 weeks in a Modified Environmental Mode in Adult and Pediatric Subjects with Seasonal Allergic Conjunctivitis Alcon Protocol C ( ) A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension Novo Nordisk Protocol NN (Secondary Site) (2007) Inhaled Mealtime Insulin with the AERx idms plus Pioglitazone versus Pioglitazone alone in Type 2 Diabetes: A 26-Week, Open-Label, Multicentre, Randomised, Parallel Trial to Investigate Efficacy and Safety Novo Nordisk Protocol NN (Secondary Site) (2007) Inhaled Mealtime Insulin with the AERx idms plus Metformin &Glimepiride versus Rosiglitazone Plus Metformin &Glimepiride in Type 2 Diabetes: A 26-Week, Open-Label, Multicentre, Randomized, Parallel Trial to Investigate Efficacy and Safety Alcon Protocol SMA (2007) Examining the Efficacy, Safety and Improved Tolerability of Travoporost BAK Free Ophthalmic Solution (Travatan-Z) Compared to prior Prostaglandin Therapy Lux Biosciences Protocol LX (2007) A Multi-center, Placebo-Controlled, Randomized, Parallel-Group Dose-Ranging Study to Assess the Efficacy and Safety of LX201 For Prevention of Corneal Allograft Rejection Episodes and Graft Failure following Penetrating Keratoplasty with LX201 Implantation in Subjects Who Are At Increased Imminological Risk LuxBiosciences Protocol LX (2007) A Multi-center, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX201 Implantation for the Prevention of Corneal Allograft Rejection Episodes or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes following Penetrating Keratoplasty 6

7 Aqumen Biopharmaceuticals Protocol AQNA-DY001 (2007) A Double-Masked, Randomized Study of the Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule during Cataract Surgery Allergan Protocol (2007) A 6 Day, Phase 3, Multicenter, Randomized, Double-Masked, Parallel Study to Compare the Safety and Efficacy of Gatifloxacin 0.5% Ophthalmic Solution BID with that of Vehicle in the Treatment of Acute Bacterial Conjunctivitis Sirion Therapeutics Protocol ST (2007) A Multicenter, Randomized, Double-Masked Trial Evaluating the Efficacy and Safety of Cyclosporine A Ophthalmic Solution, 0.1% (ST-603) Compared to Vehicle in the Treatment of Moderate to Severe Dry Eye Syndrome Allergan Protocol (2007) A Multi Center, Double-Masked, Randomized, Parallel-Group Study Evaluating the Safety and Efficacy of a New Formulation of Ketorolac Tromethamine 0.45% Ophthalmic Solution Compared with Vehicle Administered Preoperatively and Twice-Daily Postoperatively for Two Weeks for the Treatment of Anterior Segment Inflammation, Pain, and Inhibition of Surgically Induced Miosis Following Cataract Extraction with Posterior Chamber Intraocular Lens (IOL) Implantation Aqumen Protocol AQNA-DY002 (2008) A Double-Masked, Randomized Study of the Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule during Cataract Surgery Alcon Protocol C (2008) An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates ISTA Protocol CL-S&E P (2008) A Multi-Center, Double-Blind, Vehicle-Controlled, Randomized Study of Ecabet Opthalmic Solution in Patients with Dry Eye Disease Inspire Protocol (2008) A Multi-Center, Open-Label Randomized Study of the Pharmacokinetics of Azithromycin versus Moxifloxacin in Conjunctiva and Aqueous Humor Following Single or Multiple Ocular Administration of AzaSite Opthalmic Solution, 1% or Vigamox in Subjects Undergoing Routine Cataract Surgery Aton Pharma Protocol (2008) A Multi-Center Investigation of Patient Acceptability of LACRISERT Allergan Protocol (2008) An Eighteen Week, Multi-Center, Investigator-Masked, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of Bimatoprost 0.03% (Lumigan) Opthalmic Solution Once-Daily (QD) Compared with Latanoprost 0.005% (Xalatan Opthalmic Solution QD Following Six Weeks of Treatment with Xalatan QD in Subjects with Glaucoma or Ocular Hypertension ISTA CL-S&E IP (2008) Efficacy and Safety of Bromfenac Opthalmic Solution 0.18% QD vs. Xibrom (Bromfenac Opthalmic Solution) 0.09% QD for Treatment of Ocular Inflammation, Pain, and Photophobia Associate with Cataract Surgery Alcon Protocol SMA (2008) A Multi-Site, Randomized, Masked Study to Evaluate the Physical Effects of Systane versus Optive in Subjects with Moderate to Severe Dry Eye 7

8 QLT Inc. Protocol PPL GLAU 02 (2008) A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects with Primary Open Angle Glaucoma or Ocular Hypertension QLT Inc. Protocol PPL GLAU 02 - extension (2008) An Open-Label Extension Study to PPL GLAU 02 to Investigate the Long-Term Safety and Efficacy of the Punctum Plug Delivery System for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension QLT Inc. Protocol PPDEV01 (2008) A Device Evaluation Study to Assess the Physical and Clinical Performance of Prototype Punctal Plug Design Iterations Alcon Protocol C (2008) An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z Opthalmic Solution Versus Xalatan Opthalmic Solution Alcon -- Protocol C (2009) A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients INSPIRE -- Protocol number: (2009) A Multi-Center, Parallel-Group, Double-Masked, Randomized, Placebo-Controlled Study of the Effects if diquafosol tetrasodium Ophthalmic Solution, 2% in Subjects with Dry Eye Disease and a Central Corneal Staining Score of 3 (NEI Scale) Alcon Protocol C (2009) An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in the USA. ISTA Pharmaceuticals Protocol CL-PKT P (2009) A Multi-Center, Randomized, Double-Masked, Bioequivalence Study of T-PREDTM (prednisolone acetate 1% and tobramycin 0.3% ophthalmic suspension) Compared to Pred Forte (prednisolone acetate) 1% sterile ophthalmic suspension QLT Protocol PPL GLAU 03 (2009) An Open-Label Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects with Ocular Hypertension or Open-Angle Glaucoma. QLT Protocol PPL GLAU 04 (2009) An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With Benzalkonium Chloride (AT-BAK) on the Response to the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG) Sirion -- Protocol ST A Multicenter, Randomized, Double-Masked, Vehicle-Controlled Pilot Study of the Efficacy and Safety of Cyclosporine A Ophthalmic Solution (ST-603), 0.1% and 0.2% Compared to Vehicle in Subjects With Dry Eye Disease Alcon Protocol C (2009) An Evaluation of the Ocular Surface Health in Subjects Using Travoprost APS Eye Drops Solution Versus XALATAN Eye Drops Solution Alcon -- Protocol C (2009) 8

9 An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis Alcon Protocol C (2009) A Randomized, Double-Masked Study of AL % ophthalmic solution and AL % ophthalmic solution Versus AL vehicle in the Treatment of Dry Eye Inspire -- Protocol (2009) A Randomized, Multi-Center, Double-Masked, Placebo-Controlled, Parallel Group Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% versus Placebo for Two Weeks in Subjects with Blepharitis Inspire -- Protocol (2009) A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% versus Placebo for Four Weeks in Subjects with Blepharitis Fovea Pharmaceuticals Protocol # FOV1101/CLIN/201/P (2009) ORA Protocol # A Multi-Centetr, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV (Cyclosporine 0/1% or 0.2%) and Prednisolone Acetate 0.12% (Pred Mild) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients wirth Mild Ongoing Ocular Allergic Inflammation QLT Inc. Protocol PPDEV02 ( ) A Device Evaluation Study to Assess the Physical and Clinical Performance of Prototype Punctal Plug Design Iterations QLT Inc. Protocol PPL GLAU 03 (2009) An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects with Ocular Hypertension (OH) or Open Angle Glaucoma (OAG) QLT Inc. Protocol PPL GLAU 04 ) (2009) An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved with Benzalkonium Chloride (AT-BAK) on the Response to the Lataoprost Punctal Plug Delivery System (L- PPDS) in Subjects with Ocular Hypertension (OH) or Open Angle Glaucoma (OAG) QLT Inc. Protocol PPL GLAU 07) ( ) An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects with Ocular Hypertension (OH) or Open Angle Glaucoma (OAG) INSPIRE -- Protocol ( ) A Multi-Center, Double-Masked, Placebo-Controlled, Parallel-Group Randomized Study of the Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% versus Placebo for Four Weeks in Subjects with Dry Eye Disease Allergan Protocol AG ( ) A Multi-Center, Double-Masked, Randomized Study to Compare the Safety, Efficacy and Acceptability of Two Next Generation Emulsion Eye Drop Formulations with Refresh Dry Eye Therapy for Three Months in Subjects with Dry Eye Disease Bausch and Lomb Protocol 576 ( ) A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Gel, 0.5% versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery 9

10 Eli Lilly Protocol H8C-MC-LQBF (secondary site) ( ) A Phase 2 Study of the Effects of LY545694, an iglur5 Antagonist, in the Treatment of Subjects with Painful Diabetic Neuropathy Eli Lilly Protocol H8C-MC-LQBG (secondary site) ( ) A Phase 2 Study of the Effects of LY545694, an iglur5 Antagonist, in the Treatment of Subjects with Osteoarthritis Knee Pain Sun Pharma - Protocol CLR (2010) Latanoprost 0.005% Ophthalmic Solution (Test) and Xalatan (Latanoprost0.005% Ophthalmic Solution - Reference) When Administered Once Daily in Subjects With Open Angle Glaucoma or Ocular Hypertension: A Clinical Non-Inferiority Study Sun Pharma - Protocol CLR (2010) A Clinical Evaluation of Safety of SPARC s Latanoprost 0.005% Ophthalmic Solution When Administered Once Daily in Subjects With Open Angle Glaucoma or Ocular Hypertetnsion: An Open Label Study Ista Pharmaceuticals - Protocol S00007 (2010) A dose-ranging study to evaluate the safety and efficacy of bromfenac ophthalmic solution versus placebo in alleviating the signs and symptoms of dry eye disease Alcon - Protocol C (2010) A Multi-Center, Randomized, Double-Masked, Evaluation of the Safety and Efficacy of AL Ophthalmic Solution in Subjects with Allergic Conjunctivitis Associated Inflammation (POC) Fovea Pharmaceuticals Protocol FOV1101/CLIN/202/P (Ora ) (2010) A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (Pred Mild(R)) Compared to its Components and Vehicle in Patients with Mild Ongoing Ocular Allergic Inflammation Acuela Inc. Protocol ACU-RED 204 (2010) A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo in Clearing of Fluorescein Staining of the Central Cornea in Subjects with Keratoconjunctivitis Sicca (Dry Eye) Bausch & Lomb Protocol 631 (2010) A Study to Evaluate the Safety of Besivance (besifloxacin ophthalmic suspension) 0.6% Compared to Vehicle Following TID Dosing for 7 Days Omeros - Protocol OMS302 C (2010) A Study of Phenylephrine HCl's and Ketorolac Tromethamine s Ability, Alone and in Combination, to Maintain Mydriasis and Relieve Pain and Inflammation in Subjects Undergoing Unilateral Cataract Extraction with Lens Replacement (CELR) QLT, Inc. Protocol PPL GLAU 11 (2010) A Randomized, Masked, Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug Delivery System (L-PPDS) and Comparing with that of Prostaglandin Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG) Investigator Initiated Trial (Ranjan Malhotra, MD) Protocol STB-01 (2010) A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance versus Vigamox Prophylactically Pre- and Post-Operatively in Subjects Undergoing Routine Cataract Surgery 10

11 Bausch & Lomb Protocol 663 ( ) A Phase 3, Multicenter, Double-Masked, Vehicle-Controlled, Randomized, Parallel Study to Assess the Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Uncomplicated Cataract Surgery Alcon Protocol C (2011) Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain after Cataract Surgery Alcon Protocol C (2011) Aqueous Humor Concentration of Serum Amyloid A (SAA) in Patients Undergoing Cataract Surgery Alcon Protocol C (2011) A Three-Month, Randomized, Double-Masked, Parallel-Group Study with a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients with Open-Angle Glaucoma and/or Ocular Hypertension Alcon Protocol C (2011) Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% Compared to Nepafenac Ophthalmic Suspension 0.1% and Vehicle for Prevention and Treatment of Ocular Inflammation and Pain Associated with Cataract Surgery Alcon Protocol C (2011) Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients with Severe Dry Eye CXLUSA -- Protocol CXL-1 (2011) Collagen Crosslinking with Ultraviolet-A in Asymmetric Corneas TRANSCEND MEDICAL Protocol TMI (2011) A Prospective, Randomized, Comparative, Multicenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients with Open Angle Glaucoma undergoing Cataract Surgery UNITED BIOSOURCE CORPORATION (2011) Concept Elicitation and Cognitive Debriefing Interviews to Inform the Development of a Vision Symptom Questionnaire for Patients Undergoing Photorefractive Keratectomy (PRK) or LASIK Surgeries ALLERGAN Protocol 10146X-001 (2011) A Multi-Center, Investigator-Masked, Randomized, 4-Arm Parallel Group Study to Evaluate the Safety, Efficacy and Acceptability of an Investigation Unit-Dose Eye Drop Formulation in Subjects with Dry Eye Disease ALCON Protocol C (2011) Clinical Investigation of AcrySof IQ Monofocal Toric Intraocular Lens Model INSITE VISION INC Protocol C (2011) A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 (1.0% azithromycin and 0.1% dexamethasone) Compared to AzaSite Alone, Dexamethasone 0.1% Alone, and Vehicle in the Treatment of Subjects with Non-Bacterial Blepharitis 11

12 QLT INC. Protocol PPL Glau 13 (2011) A Randomized Phase 2 Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects with Ocular Hypertension (OH) or Open- Angle Glaucoma (OAG) VIRACOR-IBT LABORATORIES Protocol CL1104 (2011) A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis ACUCELA INC Protocol ACU_RED-301 (2011) A Phase 3 Study to Determine the Efficacy and Safety of Rebamipide in Subjects with Dry Eye Syndrome SANTEN Protocol (2011) A phase II, Prospective, Randomized, Double-Masked, Parallel-Group, Multi-Centered Study assessing the Safety and efficacy of two Concentration of DE-101 (0.02% and 0.05% Rivoglitazone HCI) compared to Placebo for the Treatment of Dry Eye Disease OMEROS CORPORATION Protocol OMS302-ILR-004 (2012) A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement with Phacoemulsification InSite Protocol C (2012) A Phase 3, Multicenter, Randomized Double-Masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-303 (0.75% Bromfenac in Durasite) to Durasite Vehicle in Cataract Surgery Subjects BAUSCH & LOMB Protocol 790 (2012) A Phase 3, Multicenter, Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of Mapracorat Ophthalmic Suspension 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery ALCON Protocol C (2012) Post Approval Study of the AcrySof IQ Toric High Cylinder Power IOL Models SN6AT6-SN6AT9 ALLERAN Protocol (2012) Ophthalmic AGN for the Treatment of Meibomian Gland Dysfunction UNITED BIOSOURCE CORPORATION Protocol A (2012) Focus Group Protocol to Gather Patient s Perspectives about their Experiences with Ocular Allergy Symptoms 12