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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Disease; Evaporative Dry Eye; Kerato Conjunctivitis Sicca; Evaporative Dry Eye Disease; Dry Eye, Evaporative
• Intervention / Treatment: Drug: Miebo

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Gordon Schanzlin New Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome of this clinical trial is to evaluate the safety of Miebo for contact lens wearers.	This assessment will be conducted by comparing the total corneal fluorescein staining (tCFS) score for each participant before the initiation of Miebo usage and after one month of consistent use. The total corneal fluorescein staining (tCFS) score will allow quantitative assessment of the extent of damage or irregularities on the corneal surface if present. Safe use of Miebo will be determined by an increase of tCFS score for each eye of 10% or less compared to the baseline tCFS score.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome of this clinical trial is to evaluate the tolerability of Miebo for contact lens wearers.	This assessment will be conducted by comparing the results of the CLDEQ-8 (Contact Lens Dry Eye Questionnaire-8) for each participant before the initiation of Miebo usage and after one month of consistent use. The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is a standardized and validated questionnaire designed to assess the impact of dry eye symptoms specifically in individuals who wear contact lenses. This questionnaire serves as a valuable tool to quantify and understand the subjective experiences of contact lens wearers in relation to dry eye symptoms. Successful tolerability will be quantified by am increase in the total CLDEQ-8 score of 10% or less compared to the baseline CLDEQ-8 score.	30 days

Collaborators and Investigators

• Sponsor: Gordon Schanzlin New Vision

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): April 5, 2024
• Study Completion (Actual): April 5, 2024

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Dry Eye Disease; Contact Lens
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Conjunctivitis; Keratoconjunctivitis
• Other Study ID Numbers: GSNVI-MIEBO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes