Conditions: Dry Eye
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Detailed description:
Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.

Arms:
arm 1: SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days arm 2: Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days

Interventions: intervention 1: SYSTANE HYDRATION lubricant eye drops intervention 2: Hyabak 0.15% eye drops intervention 3: 0.9% saline eye drops
Intervention descriptions: intervention 1: Preserved with POLYQUAD (polidronium chloride) 0.001% intervention 2: Preservative-free intervention 3: Preservative-free, one drop 4 times a day in each eye (run-in period)

Protocol document: