Miebo for Dry Eye Syndrome

Recruiting at 11 trial locations

Overseen By Natasa Orlic-Pleyer

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Ocular steroids, Dry eye therapy

Disqualifiers: Eye trauma, Blepharitis, Pterygium, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

97 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy

Eligibility Criteria

This trial is for individuals with Dry Eye Syndrome who are preparing for eye surgery. The study aims to include those who need accurate measurements of their eyes (biometry/keratometry) before surgery and want to improve the precision of their vision after the operation.

Inclusion Criteria

Able and willing to follow instructions, including participation in all trial assessments and visits.

Able to provide written voluntary informed consent

In the Investigator's opinion, subject has potential postoperative pinhole Snellen visual acuity of at least 20/200 in both eyes

Exclusion Criteria

I have an irregularly shaped cornea.

History of herpetic keratitis

I have significant eye surface damage or abnormal tissue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Miebo treatment preoperatively to assess its effect on biometry/keratometry accuracy

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on refractive accuracy

4-6 weeks

Treatment Details

Interventions

• Miebo™

Trial Overview The study is testing Miebo™, a treatment designed to help with Dry Eye Syndrome. It's an open-label Phase 4 trial, meaning everyone knows they're getting Miebo™, and it's being conducted across multiple centers.

Participant Groups

Group I: Miebo treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University