NCT03666884

The Comparison of 50% AS Versus PFAT+ 0.05 % COE in Severe Dry Eye Syndrome

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Seref istek · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

This is an retrospective comparative study. The designation of the patient whether to use AS 8\*1 or conventional PFAT 8\*1 plus COE 2\*1 was determined randomly. Student's paired samples t-test, independent samples Student's t-test, Wilcoxon signed-rank test and Mann-Whitney U test were used to compare data. All patients responded well to both treatments after the first 1-month treatment period, based on comparison of before and after treatment OSDI scores, Schirmer's test results, TBUT values, and OXFORD scale scores.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1	clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye
BIOLOGICAL	AS 50% eye drops 8*1	clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye

Timeline

• Start date: 2015-10-10
• Primary completion: 2016-03-15
• Completion: 2016-10-25
• First posted: 2018-09-12
• Last updated: 2018-09-12

Regulatory

• FDA-regulated drug study