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

Phase 3

Completed

• Conditions: Dry Eye
• Interventions: Drug: Topical Cyclosporine A; Drug: Placebo

• Registration Number: NCT04714099
• Lead Sponsor: Alexandria University

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 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.

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, DED was considered to be limited to dryness of the eyes due to decrease in the aqueous phase in the tear film. In 2007, the International Dry Eye Workshop discussed the definition and classification of DED and developed a new vision for the definition and the three-part classification of DED on the basis of etiology, mechanism, and severity of DED. Moreover, DED can be episodic or chronic. Episodic DED occurs when environmental or visual tasks with reduced blinking overwhelm the stability of the tear and produce symptomatic DED. Chronic DED, although aggravated by the same environmental conditions, persists continuously with symptoms and possible damage to the ocular surface. Because the tear film in DED patients is not stable and incapable to maintain the protective qualities that are important for its structure and function, patients usually experience the discomfort manifestations associated with DED such as burning, stinging, foreign body sensation, ocular fatigue, grittiness, tearing, and dryness. Patients may complain of symptoms of DED in the presence or absence of the known signs and DED may be diagnosed based only on the signs observed by a healthcare professional in the absence of symptoms reported by the patients.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.Therefore, the aim of the work is to evaluate the effect of using topical CsA in treatment of moderate to severe dry eye.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2015-12-01
• Study Completion: 2015-12-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical CsA	Topical Cyclosporine A	Group A received topical CsA 0.05% for 3 months
Control	Placebo	Placebo group

Primary Outcome Measures

Name	Time	Method
Tear Break up Time	3 months	Measuring the time lapse between last blink after instillation of fluorescein and appearance of the first dry spot on the corneal surface

Secondary Outcome Measures

Name	Time	Method
Intra ocular pressure	3 months	Intra ocular pressure measurement by applanation tonometery
Schirmer test	3 months	It was performed by placing a thin strip of filter paper in the inferior cul-de-sac following the instillation of topical anesthetic; then, the eyes are closed for 5 minutes, and the amount of wetting of the paper strip is measured. Measurement of less than 5mm is abnormal; 5-10 mm is equivocal.
Fluorescein staining (Oxford Grading Scale)	3 months	graded on a scale from 0 = none to 5 = severe by Oxford grading system
OSDI Scores	3 months	The OSDI is a valid and reliable instrument for measuring the severity of dry eye disease. Subjects in the study completed the OSDI Questionnaire each visit.