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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)

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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