NCT07243275PHASE4Recruiting
SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
Indiana University
Start Date
2/18/2026
Completion Date
9/30/2026
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 Criteria
Age Range: 18 years to No maximum
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 physiology(e.g., primary and secondary Sjogren's syndrome)
* History of ocular surgery within the past 12 months
* History of severe ocular trauma, active ocular infection or inflammation, have ever used Accutane or are currently using ocular medications.
* Women who are pregnant or breast feeding(self report)
* Subjects with a condition or in a situation, which in the investigator's opinion, may put the subject at significant rist, may confound the study results, or may significantly interfere with their participation in the study
* Subjects will not be allowed to use any other topical eye drops or other dry eye treatments beyond their assignment during the study
* Participants in clinical trial or study using a device, topical, or oral therapeutic in the past 3 months of enrollment
Interventions
DRUG
SYSTANE® PRO
DRUG
MIEBO™ (Perfluorohexyloctane, PFHO)
Conditions
Dry Eye Disease (DED)
Locations
Eye Research Foundation
Newport Beach, California 92663
United States
Indiana Universtiy School of Optometry
Bloomington, Indiana 47408
United States
Kannarr Eye Care
Pittsburg, Kansas 66762
United States
Southern College of Optometry
Memphis, Tennessee 38104
United States