Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT07243275

SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

Conditions: Dry Eye Disease (DED)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 269
Sponsor: Indiana University

Location: Eye Research Foundation Newport Beach California

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

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07243275). StuddyBuddy aggregates publicly available trial information.