Status:
COMPLETED
Topical Cyclosporine A for the Treatment of Dry Eye: A Randomized Clinical Study
Lead Sponsor:
Alexandria University
Conditions:
Dry Eye
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
Dry eye disease (DED) is known to be among the most frequently occuring ocular morbidities. It is a growing public health concern affecting 25% of patients who visit ophthalmic clinics.For many years,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04714099
Start Date
January 1 2015
End Date
December 30 2015
Last Update
January 19 2021
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