SYSTANE PRO versus MIEBO for evaporative dry eye
Comparing the Efficacy of SYSTANE® PRO to MIEBO™ for the Treatment of Dry Eye Disease
This trial will see if SYSTANE PRO works as well as MIEBO to reduce symptoms in adults with evaporative dry eye after one month of treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 4 sites (Newport Beach, California and 3 other locations) |
| Trial ID | NCT07243275 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, double-masked, multi-site non-inferiority trial comparing SYSTANE PRO (Alcon) and MIEBO (perfluorohexyloctane, PFHO; Bausch + Lomb) in adults with evaporative dry eye disease. Eligible participants meeting symptom and objective tear-film thresholds are randomized to one month of assigned treatment with change in Ocular Surface Disease Index (OSDI) as the primary endpoint. The protocol requires discontinuation of contact lens wear and other topical tear supplements to isolate the effects of the study interventions. Safety and tolerability will be monitored alongside efficacy measures during the study period.
Who should consider this trial
Good fit: Adults (≥18) with moderate evaporative dry eye—OSDI 23–50, tear break-up time ≤5 seconds, Schirmer I ≥5 mm, and corrected visual acuity ≥20/100—who can stop contact lens use and topical lubricants as required are ideal candidates.
Not a fit: Patients with primary or secondary Sjögren’s syndrome, severe aqueous-deficient dry eye, recent ocular surgery or trauma, active ocular infection or inflammation, current ocular medications, inability to stop contact lens wear, or those who are pregnant or breastfeeding are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could show that SYSTANE PRO provides symptom relief comparable to MIEBO, giving patients and clinicians more treatment choices.
How similar studies have performed: Previous studies have shown benefit for lipid- or fluorinated-oil–based eye drops including perfluorohexyloctane (MIEBO), but direct head-to-head non-inferiority comparisons with SYSTANE PRO are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Newport Beach, California and 3 other locations
- Eye Research Foundation — Newport Beach, California, United States (Recruiting)
- Indiana Universtiy School of Optometry — Bloomington, Indiana, United States (Recruiting)
- Kannarr Eye Care — Pittsburg, Kansas, United States (Recruiting)
- Southern College of Optometry — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Anna Tichenor, OD, PhD, FAAO
- Email: annatich@iu.edu
- Phone: 812-855-0520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.