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

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Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Syndrome

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * refractory to conventional treatment (those that did not respond well to entire dry eye medications containing hydroxypropyl methylellulose, carboxyl methylcellulose, polyvinyl alcohol, polyethylene glycol-propylene glycol, sodium hyaluronate, mineral oil, dextran, and carbomer artificial tears with or without preservatives) * had low TBUT (\< 5 s) (5μL of fluorescein sodium 2% eye drops was used) * low Schirmer's test I score without topical anesthesia ( basic+reflex secretion), positive corneal and conjunctival fluorescein staining (≥grade 1 according to the OXFORD Scale) (3) and an OSDI score \> 40 OSDI was a reliable and valid test for quantifying the severity of dry eye symptoms Exclusion Criteria: * active ocular infection or any other inflammation not associated with dry eye * a severe associated ocular allergy, eyelid or eyelash abnormality * current contact lens use, history of refractive surgery * associated glaucoma * current use of any type of topical eye drops other than dry eye medications * any known graft-versus host disease * known severe anemia (hemoglobin\<11 g/dL-1) * medically uncontrolled significant cerebrovascular and cardiovascular disease * pregnant and lactating patients

Outcomes

Primary Outcomes

schirmers test 1 result

clinical improvement in schirmer's test 1 result

Time frame: first month results after two treatment regimes for severe dry eye groupes, 5 minutes tear drop wetness of schirmers paper in milimeters

ocular surface oxford scale

clinical improvement in oxford scale

Time frame: first month results after two treatment regimes for severe dry eye groupes, dry eye symptom scale graded 1 to 4

ocular surface disease index scale (OSDI)

clinical improvement in OSDI

Time frame: first month results after two treatment regimes for severe dry eye groupes, dry eye symptoms graduation prepared with sample questions concluded in 2 digit numbers from 25 to 100,

tear break up time

clinical improvement in tear break up time

Time frame: first month results after two treatment regimes for severe dry eye groupes, dry eye quantitave assesment of tear break up time in seconds graded from 0 sec to 10 seconds 10 the best 0 the worst

fluorescein staining of eye

clinical improvement in fluorescein staining of eye

Time frame: first month results after two treatment regimes for severe dry eye groupes, graduation of dry eye clinical examination graded from 1 to 4

Data from ClinicalTrials.gov

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