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

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1

AS 50% eye drops 8*1

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring dry eye, autologous serum, cyclosporine ophthalmic emulsion

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

dry eye patients 1

dry eye patients 2

Arm Description

dry eye patients treated for 1 month and patient symptoms after 1 month

Outcomes

Primary Outcome Measures

schirmers test 1 result

clinical improvement in schirmer's test 1 result

ocular surface oxford scale

clinical improvement in oxford scale

ocular surface disease index scale (OSDI)

clinical improvement in OSDI

tear break up time

clinical improvement in tear break up time

fluorescein staining of eye

clinical improvement in fluorescein staining of eye

Secondary Outcome Measures

Full Information

NCT ID

NCT03666884

First Posted

February 20, 2018

Last Updated

September 9, 2018

Sponsor

Seref istek

Collaborators

Usak State Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03666884

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 10, 2015 (Actual)

Primary Completion Date

March 15, 2016 (Actual)

Study Completion Date

October 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Seref istek

Collaborators

Usak State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

dry eye, autologous serum, cyclosporine ophthalmic emulsion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Masking Description

Participants chose their treatment regime randomly

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dry eye patients 1

Arm Type

Active Comparator

Arm Description

dry eye patients treated for 1 month and patient symptoms after 1 month

Arm Title

dry eye patients 2

Arm Type

Active Comparator

Arm Description

dry eye patients treated for 1 month and patient symptoms after 1 month

Intervention Type

Drug

Intervention Name(s)

COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1

Other Intervention Name(s)

Restasis+Refresh Single Dose

Intervention Description

clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye

Intervention Type

Biological

Intervention Name(s)

AS 50% eye drops 8*1

Other Intervention Name(s)

50% autologous serum eye drops 8*1

Intervention Description

clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye

Primary Outcome Measure Information:

Title

schirmers test 1 result

Description

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

Title

ocular surface oxford scale

Description

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

Title

ocular surface disease index scale (OSDI)

Description

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,

Title

tear break up time

Description

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

Title

fluorescein staining of eye

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

şeref istek, doctor

Organizational Affiliation

Department of Ophtalmology, Usak State Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

study data can be shared

IPD Sharing Time Frame

study is finished

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

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