SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
NCT07243275 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2026-03-27
Summary
This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.
Conditions
- Dry Eye Disease (DED)
Interventions
- DRUG
-
SYSTANE® PRO
SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
- DRUG
-
MIEBO™ (Perfluorohexyloctane, PFHO)
Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.
Sponsors & Collaborators
-
Alcon Research
collaborator INDUSTRY -
Indiana University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-18
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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