SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

Comparing the Efficacy of SYSTANE® PRO to MIEBO™ for the Treatment of 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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: SYSTANE® PRO; Drug: MIEBO™ (Perfluorohexyloctane, PFHO)

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anna Tichenor, OD, PhD, FAAO; Phone Number: 812-855-0520; Email: annatich@iu.edu

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Eye Research Foundation
      • Contact: David Wirta, MD; Phone Number: 949-650-1863; Email: david.wirta@drwirta.com
  • Indiana
    • Bloomington, Indiana, United States, 47408
      • Recruiting
      • Indiana Universtiy School of Optometry
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Recruiting
      • Kannarr Eye Care
      • Contact: Shane Kannarr, OD; Phone Number: 620-235-1737; Email: skannarr@kannarreyecare.com
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Recruiting
      • Southern College of Optometry
      • Contact: Chris Lievens, OD, MS, FNAP, FAAO; Phone Number: 901-722-3250; Email: clievens@sco.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SYSTANE® PRO; SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.	Drug: SYSTANE® PRO; SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
Active Comparator: MIEBO™ (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.	Drug: MIEBO™ (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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; perfluorohexyl-octan
• Other Study ID Numbers: 28245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No