The goal of this investigational study is to determine if Systane PRO Preservative Free is non-inferior to BLINK TRIPLE CARE in the clinically significant improvement of signs and symptoms of dry eye in patients over 4 weeks.
Age: Adults ≥ 18 years.
Diagnosis: Clinical diagnosis of mild to moderate dry eye disease in at least one eye with OSDI ≥ 13 to ≤ 32 at screening.
OSDI ≥ 13 to ≤ 32 at screening.
Objective evidence: NITBUT ≤ 10 seconds in the study eye(s) at screening.
Active ocular infection or inflammation unrelated to DED (e.g., bacterial/viral conjunctivitis, active uveitis).
Severe ocular surface disease beyond typical DED (e.g., severe keratitis, Stevens-Johnson syndrome, ocular cicatricial pemphigoid).
Excessive corneal staining: CFS > grade 3 in the study eye(s).
Recent ocular surgery or procedure: ocular surgery, laser, or punctal occlusion within 6 months prior to screening.
Crossover
Systane PRO
DrugAdminister Systane Pro PF QID OU over a period of 30 days
Blink tears
DrugAdminister Blink Triple Care PF QID OU over a period of 30 days
Ocular Surface Disease Index (OSDI)
Change in OSDI score from baseline to Day 30 (non-inferiority) Quantify the severity of dry eye symptoms. Assess the impact of symptoms on vision-related activities. Evaluate the effect of environmental factors on ocular comfort. Monitor changes in symptoms over time and in response to treatment. Ocular Symptoms Light sensitivity Gritty sensation Pain or soreness Blurred vision Poor vision Vision-Related Function Difficulty reading Difficulty driving at night Difficulty working with a computer or ATM Difficulty watching television Environmental Triggers Windy conditions Low humidity Air-conditioned environments Patients report how often they experienced each symptom or limitation during the previous week using a 0-4 scale: 0 = None of the time 1. = Some of the time 2. = Half of the time 3. = Most of the time 4. = All of the time
Standard Patient Evaluation of Eye Dryness (SPEED)
Change in patient reported dry eye symptoms (SPEED) from baseline to Day 30 Patients report symptoms including: Dryness Grittiness or scratchiness Soreness or irritation Burning or watering Eye fatigue Frequency Score: 0-4 Severity Score: 0-4 Total SPEED Score: 0-28
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