CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03666884
NCT03666884Phase 4Completed
CompareCT.gov

The Comparison of 50 % Concentration Autologous Serum Eye Drops Versus Preservative Free Artificial Eye Drop Plus 0.05 % Cyclosporin Ophthalmic Emulsion in the Treatment of Severe Dry Eye Syndrome: A Randomized Comparative Study

Seref istek·interventional·Posted Sep 12, 2018·Updated Sep 12, 2018

In Brief

A Phase 4 clinical trial evaluating COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1 and AS 50% eye drops 8*1 for Dry Eye Syndrome. Completed, enrolled 36 participants.

Detailed Summary

The present study aimed to evaluate and compare the efficacy of a 1 month clinical trial of 50% AS for the treatment of severe dry eye syndrom (DES) based on Schirmer's Test, tear break-up time (TBUT), fluorescein staining, and ocular surface disease index (OSDI) scores, as compared to conventional preservative-free artificial tears (PFAT) plus 0.05% COE treatment in patients with severe DES

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
Countries--
CollaboratorsUsak State Hospital

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 12, 2018
Enrollment StartOct 10, 2015
Primary CompletionMar 15, 2016
Study CompletionOct 25, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.8 years ago

Interventions

COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1drug

clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye

AS 50% eye drops 8*1biological

clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye