Trials / Recruiting
RecruitingNCT07243275
SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
Comparing the Efficacy of SYSTANE® PRO to MIEBO™ for the Treatment of Dry Eye Disease
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- Indiana University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-02-18
- Primary completion
- 2026-09-30
- Completion
- 2026-09-30
- First posted
- 2025-11-21
- Last updated
- 2026-03-27
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07243275. Inclusion in this directory is not an endorsement.