Status:
COMPLETED
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
Lead Sponsor:
Gordon Schanzlin New Vision
Conditions:
Dry Eye
Dry Eye, Evaporative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Miebo (Perfluorohexyloctane) is a novel, non-aqueous, single entity, preservative free, ophthalmic drop. This drop was recently approved by the Food and Drug Administration (FDA) for the treatment of ...
Detailed Description
The study design is a single center, open label, double arm study with no control and no randomization. We will enroll 50 patients who are adjusted contact lens wearers who have corrected visual acuit...
Eligibility Criteria
Inclusion
- Male or female, aged ≥ 18 years of age
- Habitual contact lens wear for ≥ 60 days
- Willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol.
Exclusion
- Previous use or known allergy to Miebo
- Subjects with corneal abnormality or eye pathology that would affect the outcome in the investigator's opinion.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment.
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06176651
Start Date
September 21 2023
End Date
April 5 2024
Last Update
April 9 2024
Active Locations (1)
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1
Gordon Schanzlin New Vision Institute
San Diego, California, United States, 92037