N/A N=20 Randomized Other

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

Dry Eye Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00565669 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Change in Schirmer's Scores — -.30; -1.06 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cyclosporin A Restasis® (Drug); Blink tears (Drug); Systane (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Schirmer's Scores	-.30; -1.06	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00565669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.