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NCT Number: NCT03666884

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

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

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

AS 50% eye drops 8*1

Biological

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seref istek

Other

Collaborators

  • Usak State Hospital

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2018
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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