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

Dry Eye Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666884
• Other study ID #: UsakSH
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2015
• Est. completion date: October 25, 2016

Study information

• Verified date: September 2018
• Source: Usak State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 25, 2016
• Est. primary completion date: March 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seref istek	Usak State Hospital

References & Publications (37)

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Kojima T, Higuchi A, Goto E, Matsumoto Y, Dogru M, Tsubota K. Autologous serum eye drops for the treatment of dry eye diseases. Cornea. 2008 Sep;27 Suppl 1:S25-30. doi: 10.1097/ICO.0b013e31817f3a0e. — View Citation

Kojima T, Ishida R, Dogru M, Goto E, Matsumoto Y, Kaido M, Tsubota K. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. Am J Ophthalmol. 2005 Feb;139(2):242-6. — View Citation

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Leite SC, de Castro RS, Alves M, Cunha DA, Correa ME, da Silveira LA, Vigorito AC, de Souza CA, Rocha EM. Risk factors and characteristics of ocular complications, and efficacy of autologous serum tears after haematopoietic progenitor cell transplantation — View Citation

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Welder JD, Bakhtiari P, Djalilian AR. Limbitis secondary to autologous serum eye drops in a patient with atopic keratoconjunctivitis. Case Rep Ophthalmol Med. 2011;2011:576521. doi: 10.1155/2011/576521. Epub 2011 Dec 21. — View Citation

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	schirmers test 1 result	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
Primary	ocular surface oxford scale	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
Primary	ocular surface disease index scale (OSDI)	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,
Primary	tear break up time	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
Primary	fluorescein staining of eye	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