The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free in Providing Relief From Multiple Symptoms of Dry Eye Disease, and Its Impact on Daily Functioning and Overall Comfort in Dry Eye Subjects
Gordon Schanzlin New Vision
Summary
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.
Description
This is a prospective, randomized, controlled, crossover study designed to compare the effectiveness of preservative-free Systane PRO Preservative Free and Blink Triple Care Preservative Free in improving the signs and symptoms of mild-to-moderate Dry Eye Disease. Approximately 80 adults (≥18 years) with an OSDI score of 13-32 and best-corrected visual acuity of 20/32 or better will be enrolled. Participants will complete a 1-week artificial tear washout period prior to enrollment. Subjects will then be randomized to receive either Systane PRO Preservative Free or Blink Triple Care Preservati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Ocular surface status: CFS ≤ grade 3 (Oxford or NEI scale) in the study eye(s). * Stable medications: Systemic medications that may affect tear film must be stable ≥ 30 days prior to screening and expected to remain stable during the study. * Ability to participate: Able and willing to comply with procedures, atten…
Interventions
- DrugSystane PRO
Administer Systane Pro PF QID OU over a period of 30 days
- DrugBlink tears
Administer Blink Triple Care PF QID OU over a period of 30 days
Location
- Gordon Schanzlin New Vision InstituteLa Jolla, California