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

Study Overview
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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

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.

Official Title
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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

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1
* Biological: AS 50% eye drops 8*1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dry eye patients 1<br>dry eye patients treated for 1 month and patient symptoms after 1 month | Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1<br>* clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye<br>* Other names: Restasis+Refresh Single Dose;Biological: AS 50% eye drops 8*1<br>* clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye<br>* Other names: 50% autologous serum eye drops 8*1;|
| Active Comparator: dry eye patients 2<br>dry eye patients treated for 1 month and patient symptoms after 1 month | Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1<br>* clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye<br>* Other names: Restasis+Refresh Single Dose;Biological: AS 50% eye drops 8*1<br>* clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye<br>* Other names: 50% autologous serum eye drops 8*1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| schirmers test 1 result | clinical improvement in schirmer's test 1 result | 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 | 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 | 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 | 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 | first month results after two treatment regimes for severe dry eye groupes, graduation of dry eye clinical examination graded from 1 to 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, autologous serum, cyclosporine ophthalmic emulsion