Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 105
- Primary Endpoint
- Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
Study Overview
Brief Summary
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.
Detailed Description
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing and able to attend all study visits.
- •Diagnosis of dry eye, as specified in protocol.
- •Uses artificial tears, as specified in protocol.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Poor visual acuity, as specified in protocol.
- •Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
- •Any hypersensitivity or allergy to the investigational products or ingredients.
- •Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
- •Contact lens use within 2 weeks of Screening Visit.
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
Systane Ultra
Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Intervention: Preservative-free saline solution eyedrops (Other)
Systane Ultra
Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Intervention: Systane® ULTRA lubricant eyedrops (Other)
Optive
OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Intervention: Preservative-free saline solution eyedrops (Other)
Optive
OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
Intervention: OPTIVE® lubricating eyedrops (Other)
Outcomes
Primary Outcomes
Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
Time Frame: Baseline, Day 35
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
Secondary Outcomes
- Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)(Day 35)
- Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)(Day 35)
- Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)(Day 35)