RecruitingPhase 4NCT07243275

SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

Comparing the Efficacy of SYSTANE® PRO to MIEBO™ for the Treatment of Dry Eye Disease


Sponsor

Indiana University

Enrollment

260 participants

Start Date

Feb 18, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

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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 Foundation

Newport Beach, California, United States

Indiana Universtiy School of Optometry

Bloomington, Indiana, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Southern College of Optometry

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT07243275


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