Evaluation of SYSTANE Ultra Lubricant Eye Drops
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Tear Break-up Time
Study Overview
Brief Summary
To evaluate the safety and efficacy of two artificial tears in dry eye patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documented diagnosis of dry eyes
- •Must not have worn contact lenses for 1 week preceding enrollment
Exclusion Criteria
- •Age related
Arms & Interventions
OPTIVE
OPTIVE Lubricant Eye Drops
Intervention: Optive (Other)
SYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops
Intervention: SYSTANE Ultra (Other)
Outcomes
Primary Outcomes
Tear Break-up Time
Time Frame: Day 0, Day 7, Day 14, Day 28, and Day 42
Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Conjunctival Staining
Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42
Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Corneal Staining
Time Frame: Day 0, Day 7, Day 14, Day 28, Day 42
Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.
Secondary Outcomes
No secondary outcomes reported