NCT07054606

A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear

A Phase 4, Multicenter, Open-Label Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assess the impact of concomitant Miebo use while wearing contact lenses

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Perfluorohexyloctane ophthalmic solution	Eligible subjects will receive Miebo up to 4 times bilaterally on Day 1/Visit 1 (1 drop instilled bilaterally by site staff in-clinic while wearing contact lenses and the rest self-administered throughout the remainder of the day while wearing contact lenses). Starting on Day 2, subjects will self-administer the first drop of Miebo bilaterally before inserting contact lenses for the day. Subjects will wait 30 minutes after the first dose of Miebo to insert their contact lenses and will then instill 3 additional drops of Miebo while wearing contact lenses approximately evenly spaced throughout the rest of the day. Subjects will continue to self-administer Miebo QID bilaterally following the dosing schedule from Day 2 for approximately 30 days. Subjects are expected to record daily VAS assessments throughout the study. The VAS assessments will be collected by the sites at Visits 2, 3, and 4.

Timeline

• Start date: 2025-07-02
• Primary completion: 2025-11-03
• Completion: 2025-11-03
• First posted: 2025-07-08
• Last updated: 2025-12-18

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study