A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear
NCT07054606 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2025-12-18
Summary
Assess the impact of concomitant Miebo use while wearing contact lenses
Conditions
- Dry Eye
Interventions
- 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.
Sponsors & Collaborators
-
Bausch & Lomb Incorporated
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-02
- Primary Completion
- 2025-11-03
- Completion
- 2025-11-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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