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

NCT04714099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-01-19

No results posted yet for this study

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.

Conditions

  • Dry Eye

Interventions

DRUG

Topical Cyclosporine A

In our study we used 0.05% CsA prepared in castor oil by transferring (20ml ) of sterile castor oil in a sterile glass vial under laminar flow, removing a volume (400ul)of oil with micropipette (sterile tips), and replacing this volume with an equal volume of alcoholic CsA solution \[200mg cyclosporine in 8 ml ethanol (96%)\] under laminar flow.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Ehab Mossallam, PhD · Alexandria Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2015-12-01
Completion
2015-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714099 on ClinicalTrials.gov