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

NCT03666884 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-09-12

No results posted yet for this study

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

Conditions

  • Dry Eye Syndrome

Interventions

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

Sponsors & Collaborators

  • Usak State Hospital

    collaborator OTHER

  • Seref istek

    lead OTHER

Principal Investigators

  • şeref istek, doctor · Department of Ophtalmology, Usak State Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-10
Primary Completion
2016-03-15
Completion
2016-10-25
FDA Drug
Yes

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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 NCT03666884 on ClinicalTrials.gov