Actively Recruiting
SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
Led by Indiana University · Updated on 2026-03-27
260
Participants Needed
4
Research Sites
32 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
A
Alcon Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 63;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 63;5 seconds in both eyes
- Schirmer I test (without anesthesia) 63;5 mm in both eyes
You will not qualify if you...
- Must stop wearing contact lenses 7 days before and during the study
- No use of artificial tears or warm compresses for at least one week before and during the study
- Presence of systemic health conditions that affect tear film physiology, such as primary or secondary Sjogren's syndrome
- History of eye surgery within the past 12 months
- History of severe eye trauma, active eye infection or inflammation
- Current or past use of Accutane or use of ocular medications
- Women who are pregnant or breastfeeding
- Any condition or situation that may pose a significant risk, interfere with study participation, or affect study results as judged by the investigator
- Use of any other topical eye drops or dry eye treatments besides assigned study treatments during the study
- Participation in another clinical trial using devices or therapies within 3 months before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Eye Research Foundation
Newport Beach, California, United States, 92663
Actively Recruiting
2
Indiana Universtiy School of Optometry
Bloomington, Indiana, United States, 47408
Actively Recruiting
3
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762
Actively Recruiting
4
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
Research Team
A
Anna Tichenor, OD, PhD, FAAO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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