NCT06346340

A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The primary objective is to determine the effect of preoperative Miebo treatment on the accuracy of preoperative biometry/keratometry and predicted refraction in subjects with dry eye disease (DED) who are already scheduled for cataract surgery.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Miebo	Miebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days.

Timeline

• Start date: 2024-04-30
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2024-04-04
• Last updated: 2025-04-15

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study