Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers

NCT ID: NCT06176651

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2024-04-05

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 Meibomian Gland Disease (MGD).

All published data on Miebo has been done in non-contact lens wearers. As contact lens dropout rates seem to be an ongoing problem for practitioners, we are performing this study utilizing this novel new drug with contact lens patients to determine if the drops assist comfort in typical soft contact lens wearing patients. If the study determines that Miebo assists in the overall comfort of contact lens patients this could be a possible way to help keep patients in their contact lenses longer.

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 acuity of 20/25 or better at distance. 25 patients will be in daily disposable contact lens of varied manufacturers. The other 25 will be in monthly disposable contact lenses of varied manufacturers. Subjects will insert the Miebo eye drops four times a day, and with their contact lenses removed every day. Subjects will be required to wait at least 30 minutes before inserting their lenses after drop use. Subjects will be seen on day 0 for initial screening, on day 7 and finally on day 30. The window for visits on day 7 is +/-3 and for day 30 +/- 7 days. Visits on day 7 and 30 will be conducted at least one hour post Miebo insertion. Overall vision and comfort will be assessed during the study. The primary endpoint is to show that Miebo eye drops are safe to use in contact lens wearers. The secondary endpoint is to show changes in comfort in contact lens wearing individuals.

Conditions

Dry Eye; Dry Eye, Evaporative; Dry Eye Disease; Evaporative Dry Eye; Evaporative Dry Eye Disease; Kerato Conjunctivitis Sicca

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

This is a single arm open label study with no randomization or control group. All participants will receive the Miebo eye drop for use while enrolled in the study.

Group Type: EXPERIMENTAL

Miebo

Intervention Type: DRUG

Subjects will be instructed to use the Miebo eye drop four times per day in both eyes during their participation in clinical trial. The subjects will be required to remove their contact lenses prior to instillation of the Miebo eye drop and must wait 30 minutes before reinserting their contact lenses.

Interventions

Miebo

Subjects will be instructed to use the Miebo eye drop four times per day in both eyes during their participation in clinical trial. The subjects will be required to remove their contact lenses prior to instillation of the Miebo eye drop and must wait 30 minutes before reinserting their contact lenses.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gordon Schanzlin New Vision

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gordon Schanzlin New Vision Institute

San Diego, California, United States

Countries

United States

Other Identifiers

GSNVI-MIEBO1

Identifier Type: -

Identifier Source: org_study_id