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

September 9, 2018 updated by: Seref istek

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 50% autologous serum eye drops 8*1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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)
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
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
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
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
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
first month results after two treatment regimes for severe dry eye groupes, graduation of dry eye clinical examination graded from 1 to 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seref istek

Collaborators

Usak State Hospital

Investigators

  • Principal Investigator: şeref istek, doctor, Department of Ophtalmology, Usak State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2015

Primary Completion (Actual)

March 15, 2016

Study Completion (Actual)

October 25, 2016

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

September 9, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 9, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UsakSH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

study data can be shared

IPD Sharing Time Frame

study is finished

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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