NCT07243275 SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
| NCT ID | NCT07243275 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Indiana University |
| Condition | Dry Eye Disease (DED) |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 260 participants in total. It began in 2026-02-18 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07243275 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Disease (DED). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07243275 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07243275 currently recruiting?
Yes, NCT07243275 is actively recruiting participants. Contact the research team at annatich@iu.edu for enrollment information.
Where is the NCT07243275 trial being conducted?
This trial is being conducted at Newport Beach, United States, Bloomington, United States, Pittsburg, United States, Memphis, United States.
Who is sponsoring the NCT07243275 clinical trial?
NCT07243275 is sponsored by Indiana University. The trial plans to enroll 260 participants.