Overview
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 Preservative Free, instilled four times daily in both eyes for 30 days. Following a 1-week washout period, subjects will cross over to the alternate treatment for an additional 30 days.
Participants will attend five study visits (Baseline, Day 7, Day 30, Day 44, and Day 67) and complete a daily dosing diary to monitor treatment compliance. At each visit, assessments will include the Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness (SPEED) questionnaires, best-corrected visual acuity, non-invasive tear breakup time (NI-TBUT), corneal fluorescein staining (CFS), and adverse event evaluation. Refraction will be performed at baseline only.
The primary efficacy analyses will evaluate changes in dry eye symptoms (OSDI and SPEED) and objective tear film measures (NI-TBUT and CFS) from baseline through each treatment period, with direct comparison between the two artificial tear formulations. Visual acuity is expected to remain stable throughout the study. An interim analysis will be conducted after the first 30 participants have completed enrollment to determine whether the study should continue to full enrollment based on evidence of a meaningful treatment difference.
Eligibility
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, attend visits, and provide written informed consent.
- Contraception: Women of childbearing potential must agree to use an acceptable method of contraception for the study duration and have a negative pregnancy test at screening.
Exclusion Criteria:
- 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.
- Current or prior use within 6 months before screening of either study drop (Systane PRO PF or Blink Triple Care PF)
- Contact lens wear: soft or rigid contact lens use within 7 days prior to baseline, or unwillingness to discontinue lenses for the study; consider extending to 14 days if desired.
- Use of topical ophthalmic medications that cannot be discontinued (e.g., topical antibiotics, corticosteroids).
- Recent investigational product use: participation in another interventional trial or investigational product use within 30 days prior to screening.
- Known hypersensitivity: allergy to any component of Systane PRO PF or Blink Triple Care PF.
- Confounding systemic conditions: systemic diseases or medications that, in the investigator's judgment, could significantly affect tear production or ocular surface health (e.g., uncontrolled autoimmune disease, recent initiation/change of systemic medications known to affect tear production within 30 days).
- Severe visual impairment in the study eye(s) not attributable to DED that would interfere with assessments.
- Pregnancy or breastfeeding.
- Investigator discretion: any medical, psychiatric, or social condition that would preclude safe participation or reliable completion of study procedures.
