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Completed

NCT Number: NCT07243275

SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eye Research Foundation, Newport Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SYSTANE® PRO

Drug

SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.

MIEBO™ (Perfluorohexyloctane, PFHO)

Drug

Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.

Primary outcomes

  1. OSDI Scores

    Time frame: Between group difference at 1 month

    Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 1-month visit (0-100 scale).

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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