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

NCT06176651 | Completed Phase 4 FDA Drug

• 1 other identifier: GSNVI-MIEBO1
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary outcome of this clinical trial is to evaluate the tolerability of Miebo for contact lens wearers.

  30 days

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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

Interventions

Miebo 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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gordon Schanzlin New Vision: lead

Study Sites (1)

Gordon Schanzlin New Vision Institute

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

perfluorohexyl-octan

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 20, 2023
• Study Start: September 21, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)