SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

Part of paid clinical trials in Newport Beach, California.

Sponsor
Indiana University
Study ID
NCT07243275
Phase
PHASE4
Status
Recruiting

Conditions

  • Dry Eye Disease (DED)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SYSTANE® PRO — DRUG
    SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
  • MIEBO™ (Perfluorohexyloctane, PFHO) — DRUG
    Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.

Study Details

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.

Key Dates

Start date
Feb 18, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

OSDI Scores [ Time Frame: Between group difference at 1 month ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Eye Research FoundationNewport BeachCalifornia92663
David Wirta, MD
949-650-1863
Indiana Universtiy School of OptometryBloomingtonIndiana47408-
Kannarr Eye CarePittsburgKansas66762
Shane Kannarr, OD
620-235-1737
Southern College of OptometryMemphisTennessee38104
Chris Lievens, OD, MS, FNAP, FAAO
901-722-3250

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