3 rd line 2 nd line 1 st line This policy statement is approved by Halton, Knowsley, Liverpool, Southport and Formby, South Sefton, St Helens, Warrington and West Lancashire CCGs Halton Knowsley Liverpool Southport and Formby South Sefton St Helens Warrington West Lancashire PAN MERSEY AREA PRESCRIBING COMMITTEE GUIDELINES FOR THE NON-SPECIALIST MANAGEMENT OF DRY EYE SYMPTOMS Pan Mersey Area Prescribing Committee The diagnosis of dry eye symptoms is generally made on the history. Symptoms tend to affect both eyes. One of the most common causes of dry eyes is an unstable tear film due to blepharitis or other diseases of the eyelids such as that associated with acne rosacea. In such cases, although some of the symptoms may be temporarily relieved using artificial tears, they soon recur and patients then end up trying many different types and formulations of artificial tears. If blepharitis is present, it can be recognised by red and inflamed lid margins often with the presence of scales along the eye lashes. In such cases application of a topical antimicrobial ointment such as chloramphenicol to the lid margins can be helpful. If acne rosacea is present this is usually accompanied by obstruction of the meibomian glands along the lid margin. This often responds to warm lid compresses, for example a cotton ball placed in warm water and then applied to the lids of a closed eye for 5-10 seconds in the mornings and evenings. IF TREATMENT WITH AN ARTICIFICAL TEARS PREPARATION IS INDICATED: Is the answer to any of the following yes? Referral to secondary care recommended if: Symptoms are severe or the diagnosis is uncertain e.g. marked redness, photophobia, acute onset or unilateral disease. Symptoms are uncontrolled despite adequate treatment (patient reliably taking their drops and risk factors minimised). Vision deteriorates or cornea is affected. Assessment for underlying disease needed. No 1. Does the patient wear contact lenses and cannot avoid wearing them during treatment? or 2. Is the patient taking other eye medications which contain preservatives? or 3. Does the patient have an existing documented allergy to preservatives? Yes Preserved preparations Hypromellose 0.3% eye drops or polyvinyl alcohol 1.4% eye drops Carbomer-980 0.2% eye gel Optive Fusion eye drops a or Systane eye drops or sodium hyaluronate eye drops a,c At any stage in treatment, consider switching to a preservative free option if the patient: develops an allergy to preservatives (e.g. worsening symptoms despite adequate treatment) is requiring frequent administration (>6 times per day) b or will require prolonged treatment b Preservative-free (PF) preparations Hypromellose 0.3% PF eye drops or polyvinyl alcohol PF eye drops Carbomer-980 0.2% PF eye gel Carmellose 0.5% PF eye drops or Systane PF eye drops or sodium hyaluronate PF eye drops d a Contains preserving system that disintegrates on contact with the eye. May be considered in patients with a known allergy to another preservative (e.g. benzalkonium chloride). b Patients requiring frequent administration of 1 st line preserved treatments could be trialled on 2 nd line preserved options as the required frequency of administration may be lower with these products. c The product with the lowest acquisition cost should be selected. At the time of writing this is Lumecare 0.15% eye drops. d The product with the lowest acquisition cost should be selected. At the time of writing this is Vismed single dose 0.18% eye drops. Patients should be given at least a 4 week trial of treatment at each step before reviewing. Patients who continue to have symptoms despite adequate treatment with 2 nd /3 rd line treatment options should be considered for referral to an ophthalmologist for assessment. Version: 1 Review date: January 2017 (or earlier if there is significant new evidence relating to this recommendation)
GENERAL SUPPORTING INFORMATION About dry eyes Tears are made up from a complex mixture of water, salts, proteins, lipids and mucins. The tear film is made up of three distinct layers, each having its own role in ensuring good tear maintenance: aqueous, lipid and mucin. Tears are produced under nervous and hormonal control by the lacrimal gland (responsible for producing the aqueous components of tears), the meibomian gland (producing lipid components) and the conjunctival goblet cells (which produce mucin). Dry eye symptoms are the final outcome of any process which alters the production of the components of the tear film. Prevalence of dry eye symptoms Prevalence increases with age In people over 65 years of age, the reported prevalence is as high as 33%. It is 50% more common in women than men. Causes of dry eyes Most people with dry eyes have no measurable abnormality of tear production, and no serious disease affecting tear composition. Common causes of dry eye symptoms include: Decreased tear production, commonly caused by: Blepharitis Adverse drug reaction Allergic conjunctivitis Increased evaporation of tears, commonly caused by: Low humidity (e.g. from air conditioning) Low blink rate (e.g. prolonged computer use) High wind velocity Adverse drug reaction Allergic conjunctivitis Less common causes of dry eye symptoms include: lagophthalmos, Sjörgen s syndrome, trauma, dehydration, diet low in omega-3 fatty acids, keratoconjunctivitis, complications of contact lens usage, ocular manifestations of HIV disease, post-stevens Johnson syndrome, exophthalmos, blink disorders (e.g. Parkinson s disease), vitamin A deficiency. Drugs associated with dry eye symptoms: antihistamines, tricyclic antidepressants, SSRIs, diuretics, beta-blockers, antimuscarinics (e.g. antipsychotics), isotretinoin. Non-pharmacological management of dry eyes Advise that the symptoms of dry eyes can be reduced by taking suitable precautions: If using computer for prolonged period, ensure screen is below eye level, avoid staring at the screen, and take frequent breaks to blink or close eyes Reducing contact lens use, if these are source of irritation Smoking cessation may reduce symptoms Stopping medication that may cause or exacerbate dry eyes symptoms Use of a humidifier to moisten ambient air Preservatives and dry eye symptoms Ocular surface inflammation can be exacerbated by preservatives used in ocular preparations. Benzalkonium chloride (BAK) is commonly used in ocular preparations and it has been shown to destabilise the tear film and damage the corneal epithelium. In patients with mild symptoms, BAKcontaining products may be well tolerated. In patients with more severe symptoms, BAK toxicity is more likely due to reduced tear secretions. Other preservatives may also cause toxicity. Patients with severe dry eye symptoms should always be prescribed PF preparations. Preservative-toxicity is dose related and patients requiring preserved drops >6 times per day should be reviewed and have an alternative preparation prescribed. Licensing of products for treatment of dry eyes Increasingly, ocular lubricants are being licensed as medical devices rather than medicinal products. Medical devices do not have a summary of product characteristics. Medical devices can be identified as they carry the CE mark. Medical devices only require safety data to gain the CE mark and therefore clinical trial data to support the use of these products and to define their place in therapy is not available. References 1. The Ocular Surface, 2007. Report of the International Dry Eye workshop (DEWS) [online]. Availabe at: www.tearfilm.org/dewsreport 2. NICE Clinical Knowledge Summary: Dry Eye Syndrome [online] Available at: http://cks.nice.org.uk 3. Electronic Medicines Compendium (various SPCs) [online] Available at: www.medicines.org.uk/emc 4. Electronic Drug Tariff. September 2014 5. Patient Plus. Dry Eyes Syndrome [online] Available at: www.patient.co.uk
FORMULARY PRESCRIBING INFORMATION HYPROMELLOSE Preserved hypromellose 0.3% eyes drops (prescribed generically) should be used first line, where appropriate, for the management of mild-moderate dry eye symptoms in non-specialist settings. Normal dose is 1 drop to both eyes when required. Hypromellose may need to be given very frequently (up to hourly) to provide adequate symptom relief. Compliance may be affected if drops are required hourly. Consider an alternative if patient finds hourly drops difficult to manage. Hypromellose 0.3% eye drops (10ml) GREEN Likely BAK consult individual product literature 1.04 Hypromellose 0.5% eye drops (Isopto-Plain, 10ml) AMBER BAK 0.81 Hypromellose 1% eye drops (Isopto-Alkaline, 10ml) AMBER BAK 0.94 Hypromellose 0.3% single dose units GREEN Preservative-free 5.75 Hypromellose 0.3% eye drops (10ml) GREEN Preservative-free 5.75 POLYVINYL ALCOHOL (PVA) PVA-containing products can be used as an alternative first-line option in place of hypromellose. PVA may be longer acting than hypromellose and may also be an option in patients from whom hypromellose does not provide adequate relief. Normal dose is 1 drop to both eyes when required. There is no evidence that any PVA-containing product is superior to another. Therefore, the product with the lowest acquisition cost should be prescribed. This is currently Sno-Tears. Polyvinyl alcohol 1.4% eye drops (Sno-Tears, 10ml) GREEN BAK 1.06 Polyvinyl alcohol 1.4% ophthalmic solution (Liquifilm Tears PF, 30 units) GREEN Preservative-free 5.35 CARBOMERS Carbomer gel preparations may have a longer residency time in the eye than 1 st line eye drops and can reduce frequency of administration required to four times daily. Carbomer preparations are considered an appropriate second line alternative where first line treatments have failed. The product with the lowest acquisition cost should be prescribed. Normal dose is 1 drop to both eyes when required (normally up to four times daily). Carbomer 980 0.2% eye drops (10g) GREEN Cetrimide 2.80 Artelac Nighttime gel (10g) GREEN Cetrimide 2.96 Clinitas Carbomer gel (10g) GREEN Cetrimide 1.49 Lumecare Carbomer gel (10g) GREEN Cetrimide 2.10 Xailin gel (10g) GREEN Preservative-free in the eye 3.25 Viscotears single-dose units GREEN Preservative-free 5.42
PARAFFINS Paraffin-containing eye ointments are high viscosity lubricant preparations. They lubricate the eye and protect against epithelial erosion. They are ordinarily reserved for severe disease or for patients who require additional night time dosing in addition to daytime eye drops. These products may cause discomfort and blurring of the vision when applied. They are normally reserved for night time administration. They should never be used with contact lenses. Limited evidence suggesting one preparation is superior to any other, although constituents vary and so patient preference and tolerability may vary. The product with the lowest acquisition cost should be prescribed. Available products are preservative-free but may contain lanolin and/or wool fat. Some products have extended shelf-life consult individual product literature. Normal dose is 1 application to both eyes at bedtime. Lacri-Lube eye ointment GREEN Preservative-free 3.32 VitA-Pos eye ointment GREEN Preservative-free 2.75 Xailin Night GREEN Preservative-free 2.49 Simple eye ointment GREEN Preservative-free 3.46 CARMELLOSE Carmellose sodium 0.5% containing products are recommended as a 3 rd line option in the management of dry eye symptoms. Optive products can be used for up to 6 months after opening. Normal dose is 1 drop to affected eye(s) when required. Optive Fusion (carmellose sodium 0.5% / sodium hyaluronate 0.1%, 10ml) GREEN Purite 7.49 Optive Plus (carmellose sodium 0.5% with glycerol and castor oil, 10ml) AMBER Purite 7.49 Celluvisc 0.5% single dose eye drops GREEN Preservative-free 4.80 Xailin Fresh (carmellose sodium 0.5%, 30 units) GREEN Preservative-free 3.84 Celluvisc 1% single dose eye drops AMBER Preservative-free 3.00 HYDROXYPROPYL GUAR Systane eye drops are recommended as a 3 rd line option in the management of dry eye symptoms. Systane Ultra contains the same active ingredients as Systane with the addition of sorbitol and AMP. The suggested benefit of Systane Ultra over Systane is that it is a liquid preparation (due to the AMP) when administered and is not associated with blurring of vision at the time of administration. However, Systane Ultra is more expensive than Systane and this proposed benefit is not felt to offset the higher cost. Systane products can be used for 6 months after opening. Normal dose is 1 drop to affected eye(s) when required. Systane eye drops (10ml) GREEN Propylene glycol 4.66 Systane single dose eye drops (28 units) GREEN Preservative-free 4.66 Systane Ultra eye drops (10ml) AMBER Propylene glycol 6.69 Systane Ultra single dose eye drops AMBER Preservative-free 6.69
SODIUM HYALURONATE Sodium hyaluronate containing preparations should be recommended by a specialist. There is limited evidence to determine the optimum strength of sodium hyaluronate eye drops. It is recommended that the product with the lowest acquisition cost is prescribed. Some products have extended shelf-life consult product literature. Normal dose is 1 drop to affected eye(s) when required (normally up to four times per day). Artelac Rebalance eye drops (sodium hyaluronate 0.15%, 10ml) AMBER 4.00 Clinitas single dose eye drops (sodium hyaluronate 0.4%, 30 units) AMBER Preservative-free 5.70 Hyabak eye drops (sodium hyaluronate 0.15%, 10ml) AMBER Preservative-free 7.99 Hylo-Care - eye drops (sodium hyaluronate 0.1% and dexpanthenol AMBER Preservative-free 10.30 2%, 10ml) Hylo-Forte eye drops (sodium hyaluronate 0.2%, 10ml) AMBER Preservative-free 9.50 Hylo-Tear eye drops (sodium hyaluronate 0.1%, 10ml) AMBER Preservative-free 8.50 Lumecar eye drops (sodium hyaluronate 0.15%, 10ml) AMBER 3.97 Vismed eye drops (sodium hyaluronate 0.18%, 10ml) AMBER Preservative-free 6.81 Vismed single dose eye drops (sodium hyaluronate 0.18%, 20 units) AMBER Preservative-free 5.10 Vismed eye gel (sodium hyaluronate 0.3%, 10ml) AMBER Preservative-free 7.95 Vismed single dose eye gel (sodium hyaluronate 0.3%, 20 units) AMBER Preservative-free 5.98 CICLOSPORIN Ciclosporin ophthalmic preparations are used to increase tear production in people with severe dry eye symptoms. They work by reducing inflammation in the eye which allows tear production. Currently, all ciclosporin ophthalmic preparations are unlicensed, and prescribing must be retained in secondary care. Normal dose is 1 drop to affected eye(s) every 12 hours, but may be more frequently. Ciclosporin 0.2% eye ointment RED Preservative-free 56.62 Ciclosporin 0.05% single use eye drops RED Preservative-free 119.75 Ciclosporin 0.06% eye drops RED Preservative-free 19.36 Ciclosporin 2% eye drops RED Preservative-free 47.25
ACETYLCYSTEINE Acetylcysteine does not treat the symptoms of dry eyes but may be recommended by a specialist, often in combination with ocular lubricants, where there is evidence of impaired or abnormal mucus production. Preservative-free preparations are unlicensed specials and prescribing must be retained in secondary care. Normal dose is 1-2 drops in the affected eye(s) three to four times a day. Acetylcysteine 5% eye drops (Ilube, 10ml) AMBER BAK 10.09 Acetylcysteine 5% preservative-free eye drops RED Preservative-free 43.54 Acetylcysteine 10% preservative-free eye drops RED Preservative-free