N/A
Completed N=20
Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms
Source: ClinicalTrials.gov NCT00565669 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Change in Schirmer's Scores — -.30; -1.06 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Schirmer's Scores |
-.30; -1.06 | — |
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.
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. Informational only — not medical advice.