Clinical trial NCT06176651: Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
Official title: Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Dry Eye, Evaporative
Dry Eye Disease
Evaporative Dry Eye
Evaporative Dry Eye Disease
Kerato Conjunctivitis Sicca
Keywords: Contact Lens
Dry Eye Disease
Lead sponsor: Gordon Schanzlin New Vision
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary outcome of this clinical trial is to evaluate the safety of Miebo for contact lens wearers.
timeFrame: 30 days
Secondary outcomes:
measure: The secondary outcome of this clinical trial is to evaluate the tolerability of Miebo for contact lens wearers.
timeFrame: 30 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Gordon Schanzlin New Vision Institute
state: California
Study officials:
References: