NCT07243275 · Indiana University
SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
What this study is about
This is a forward-looking, randomly assigned, double-masked, multi-site clinical trial designed to compare the effectiveness of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Newport Beach, California
- Bloomington, Indiana
- Pittsburg, Kansas
- Memphis, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations