Comparing the Efficacy of SYSTANE® PRO to MIEBO™ for the Treatment of Dry Eye Disease
Indiana University
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults\>=18 years of age * Corrected visual acuity of 20/100 or better in both eyes * Ocular Surface Disease Index \[OSDI\] scores between 23 and 50 units \[inclusive\] * Tear break up time score of \<=5 seconds in both eyes * Schirmer I test (without anesthesia) \>=5 mm in both eyes Exclusion Criteria: * Discontinue contact lens wear starting 7 days prior and throughout the study * Artificial tears and warm compresses should not be used for at least one week prior to enrollment and throughout the study * Systemic health conditions that are known to alter tear film phy…
Interventions
- DrugSYSTANE® PRO
SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
- DrugMIEBO™ (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.
Locations (4)
- Eye Research FoundationNewport Beach, California
- Indiana Universtiy School of OptometryBloomington, Indiana
- Kannarr Eye CarePittsburg, Kansas
- Southern College of OptometryMemphis, Tennessee