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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
Preserved with POLYQUAD (polidronium chloride) 0.001%
Preservative-free
Preservative-free, one drop 4 times a day in each eye (run-in period)
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Day 42
Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42
The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.
Time frame: Baseline (Day 0), Day 42
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42
The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.
Time frame: Baseline (Day 0), Day 42
Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42
TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Day 42
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