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The Comparison of 50% AS Vers...

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

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-10

Study Completion Date

2016-10-25

Brief Summary

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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

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Detailed Description

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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

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 syndrom

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants chose their treatment regime randomly

Study Groups

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dry eye patients 1

dry eye patients treated for 1 month and patient symptoms after 1 month

Group Type ACTIVE_COMPARATOR