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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
Sponsor:
Collaborator:
Usak State Hospital
Information provided by (Responsible Party):
Seref istek, Usak State Hospital

Study Description
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Brief 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

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

Detailed Description:
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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Seref istek
Usak State Hospital
Investigators
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Principal Investigator: şeref istek, doctor Department of Ophtalmology, Usak State Hospital
  Study Documents (Full-Text)

Documents provided by Seref istek, Usak State Hospital:
Statistical Analysis Plan  [PDF] May 11, 2016
Study Protocol  [PDF] May 11, 2016
Informed Consent Form  [PDF] October 11, 2015

More Information
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Publications of Results:

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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

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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
Keywords provided by Seref istek, Usak State Hospital:
dry eye
autologous serum
cyclosporine ophthalmic emulsion
Additional relevant MeSH terms:
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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