Evaluation of SYSTANE® BALANCE on Conjunctival Staining (CS) Visual Performance (VP) and Tear Film Kinetics (TFK) in Dry Eye Subjects With Lipid Deficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 91
- Primary Endpoint
- Mean Bulbar Conjunctival Staining
Study Overview
Brief Summary
The purpose of this study is to evaluate the repeated use of SYSTANE® BALANCE on stabilizing the tear film of dry eye patients with an unstable tear film.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-contact lens wearer;
- •Symptomatology as defined by the Ocular Surface Disease Index (OSDI) questionnaire;
- •Lipid deficiency;
- •Best visual acuity of 6/9 or better in each eye;
- •Willingness to adhere to the instructions set in the clinical protocol;
- •Signature of the subject informed consent form;
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Use of systemic medication which might produce dry eye side effects;
- •Systemic disease which might produce dry eye side effects;
- •Active or recent ocular inflammation or infection;
- •Use of ocular medication;
- •Significant ocular anomaly;
- •Previous ocular surgery;
- •Previous use of Restasis;
- •Any medical condition that might be prejudicial to the study;
- •Pregnant or lactating;
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
SYSTANE BALANCE
SYSTANE® BALANCE eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Intervention: SYSTANE® BALANCE eyedrops (Other)
Minims Saline
Minims® Saline 0.9% eyedrops, 1 drop 4 times a day for a continuous period of 1 month
Intervention: Minims® Saline 0.9% eyedrops (Other)
Outcomes
Primary Outcomes
Mean Bulbar Conjunctival Staining
Time Frame: Month 1
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
Secondary Outcomes
- Non Invasive Tear Film Break-up-time (NIBUT)(Month 1)
- High Contrast logMAR Time Controlled Visual Acuity (TCVA)(Month 1)