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

Seref istek

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndrome

Treatments: Drug: COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1; Biological: AS 50% eye drops 8*1

Study type: Interventional

Funder types: Other

Identifiers

NCT03666884

UsakSH

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

dry eye patients 1

Active Comparator group

Description:

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

Treatment:

Biological: AS 50% eye drops 8*1

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

dry eye patients 2

Active Comparator group

Description:

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

Treatment:

Biological: AS 50% eye drops 8*1

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