Topical Cyclosporine A for the Treatment of Dry Eye: A Randomized Clinical Study

• Status: Completed
• Trial end date: 2015-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Since the initial description, the therapeutic efficacy of CsA for human KCS has been well documented, with evidence ranging from several small single center randomized double-masked clinical trials to several large multicenter randomized, double-masked clinical trials.(10-12) Therefore, the aim of the work is to evaluate the effect of using topical CsA in treatment of moderate to severe dry eye.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexandria University
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• We included all patients with moderate to severe dry eye disease (grade 3 or grade 4) with the following criteria: The tear film break up time ≤5 seconds for grade 3 and immediate for grade 4, schirmer test with anesthetic is ≤5 millimeters for grade 3 and ≤2 millimeters for grade 4, corneal or conjunctival staining pattern with fluorescein is abnormal and consistent with an abnormal tear film. Oxford grade II or more, meibomian gland dysfunction is documented (inspissation of the meibomian gland orifices, pitting and neovascularization of the eyelid margins) and one or more moderate (≥2+) dry eye related symptoms; including itching, burning, blurred vision, foreign body sensation, photophobia, veiling, and soreness or pain

Exclusion Criteria:

• Exclusion criteria included Post LASIK patients, Post radiation fibrosis of lacrimal gland, Vitamin A deficiency, Conjunctival scarring (advanced trachoma, chemical burn, OCP), Drugs (anti-histaminics, anti-cholinergic, anti-psychotics, selective serotonin uptake inhibitors), Patients with familial dysautonomia (Riley-Day syndrome), Use of systemic or topical CsA in the previous 90 days.