Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms

NCT00565669 | Completed Results

• 1 other identifier: SEI-07-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

Conditions

Dry Eye Syndrome

Keywords

Treatment; Dry Eye

Outcome Measures

Primary Outcomes (1)

• Change in Schirmer's Scores

  The Schirmer score is a score on a scale - minimum is 0 and the highest is 35 mm. Above 15 mm is normal and less than 5 is severe dry eyes. A positive score means there was an improvement, 0 will be no change from baseline and a negative one that there was a decreased in tears. This change was calculated by subtracting the baseline value from the 3 months value (3 mo Schirmer's - baseline Schirmer's = amount of change).

  baseline to 3 months

Study Arms (2)

Blink Tears

EXPERIMENTAL

Drug: Cyclosporin A Restasis®; Drug: Blink tears

Systane

EXPERIMENTAL

Drug: Cyclosporin A Restasis®; Drug: Systane

Interventions

Cyclosporin A Restasis® DRUG

Blink Tears; Systane

Blink tears DRUG

blink tears to be used twice a day

Blink Tears

Systane DRUG

systane to be used twice a day

Systane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have dry eye.
• Age: 18 years and older.
• Males or females
• Up to grade 3 conjunctival staining.
• Score of no more than 4 on the Subjective Evaluation of Symptoms of Dryness (SESOD) at screening.
• Currently using Restasis to treat dry eye syndrome (at least for 3 months prior to enrollment).
• Willing and able to comply with scheduled visits and other study procedures.

You may not qualify if:

• Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months without improvement.
• Known contraindications to any study medication or ingredients.
• Planned use of contact lenses (unless discontinued use more than 30 days prior to randomization.
• Contact lens use during the active treatment portion of the trial.
• Active ocular allergies.
• Ocular surgery within the past 3 months.
• Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
• Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable.
• Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
• Participation in (or current participation) any investigational drug or device trial.
• Conjuctival staining grade 4.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina, Storm Eye Institute

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Helga Sandoval
• Organization: Carolina Eye

hps@cepmd.com

Study Officials

• Kerry D. Solomon, MD

  Medical University of South Carolina, Storm Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 7, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-10

Locations

US (1)