Dry Eye Clinical Trial
Official title:
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
Verified date | April 2024 |
Source | Gordon Schanzlin New Vision |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | April 5, 2024 |
Est. primary completion date | April 5, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Gordon Schanzlin New Vision Institute | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Gordon Schanzlin New Vision |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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