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

NCT03666884 | Completed Phase 4 FDA Drug

• 1 other identifier: UsakSH
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dry Eye Syndrome

Keywords

dry eye; autologous serum; cyclosporine ophthalmic emulsion

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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,

• 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

• 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

Study Arms (2)

dry eye patients 1

ACTIVE COMPARATOR

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

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

dry eye patients 2

ACTIVE COMPARATOR

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

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

Interventions

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

Also known as: Restasis+Refresh Single Dose

dry eye patients 1; dry eye patients 2

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

Also known as: 50% autologous serum eye drops 8*1

dry eye patients 1; dry eye patients 2

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seref istek: lead
• Usak State Hospital: collaborator

Related Publications (37)

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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. Bone Marrow Transplant. 2006 Aug;38(3):223-7. doi: 10.1038/sj.bmt.1705426. Epub 2006 Jun 19.

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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.

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MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• şeref istek, doctor

  Department of Ophtalmology, Usak State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants chose their treatment regime randomly
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Uşak University Training and Research Hospital, Department of Ophthalmology, Eye Clinic, Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: September 12, 2018
• Study Start: October 10, 2015
• Primary Completion: March 15, 2016
• Study Completion: October 25, 2016
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: study is finished