The Comparison of 50% AS Versus PFAT+ 0.05 % COE in Severe Dry Eye Syndrome
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ClinicalTrials.gov Identifier: NCT03666884 |
Recruitment Status :
Completed
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Syndrome | Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1 Biological: AS 50% eye drops 8*1 | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Participant, Outcomes Assessor) |
Masking Description: | Participants chose their treatment regime randomly |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | October 10, 2015 |
Actual Primary Completion Date : | March 15, 2016 |
Actual Study Completion Date : | October 25, 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: dry eye patients 1
dry eye patients treated for 1 month and patient symptoms after 1 month
|
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
Other Name: Restasis+Refresh Single Dose 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
Other Name: 50% autologous serum eye drops 8*1 |
Active Comparator: dry eye patients 2
dry eye patients treated for 1 month and patient symptoms after 1 month
|
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
Other Name: Restasis+Refresh Single Dose 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
Other Name: 50% autologous serum eye drops 8*1 |
- schirmers 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 ]clinical improvement in schirmer's test 1 result
- ocular surface oxford scale [ Time Frame: first month results after two treatment regimes for severe dry eye groupes, dry eye symptom scale graded 1 to 4 ]clinical improvement in oxford scale
- ocular surface disease index scale (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, ]clinical improvement in OSDI
- 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 ]clinical improvement in tear break up time
- 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 ]clinical improvement in fluorescein staining of eye

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Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666884
Principal Investigator: | şeref istek, doctor | Department of Ophtalmology, Usak State Hospital |
Documents provided by Seref istek, Usak State Hospital:
Responsible Party: | Seref istek, Uşak University Training and Research Hospital, Department of Ophthalmology, Eye Clinic, Principal Investigator, Usak State Hospital |
ClinicalTrials.gov Identifier: | NCT03666884 |
Other Study ID Numbers: |
UsakSH |
First Posted: | September 12, 2018 Key Record Dates |
Last Update Posted: | September 12, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | study data can be shared |
Supporting Materials: |
Clinical Study Report (CSR) Analytic Code |
Time Frame: | study is finished |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
dry eye autologous serum cyclosporine ophthalmic emulsion |
Keratoconjunctivitis Sicca Dry Eye Syndromes Syndrome Disease Pathologic Processes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Cyclosporine |
Ophthalmic Solutions Cyclosporins Pharmaceutical Solutions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors |