Dry EyePhase 4NCT06176651
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
A Phase 4 study testing Miebo in people with Dry Eye and Dry Eye, Evaporative, run by Gordon Schanzlin New Vision at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Dry Eye, Evaporative, Dry Eye Disease
- What is being tested?
- Miebo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 5 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gordon Schanzlin New Vision Institute
San Diego, California, 92037
About this study
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.
Read the 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
- Being tested
- Miebo
- Keywords
- Contact Lens, Dry Eye Disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MieboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Miebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start21 Sep 2023
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gordon Schanzlin New Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176651
- Sponsor's protocol ID
- GSNVI-MIEBO1
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT06176651
- Acronym / sponsor ID
- GSNVI-MIEBO1
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Gordon Schanzlin New VisionUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: MieboThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MieboSubjects 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. | Drug | Experimental Arm |
Primary outcome
The primary outcome of this clinical trial is to evaluate the safety of Miebo for contact lens wearers.
Time frame: 30 days
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.
1 secondary outcome
The secondary outcome of this clinical trial is to evaluate the tolerability of Miebo for contact lens wearers.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Miebo in people with Dry Eye and Dry Eye, Evaporative, run by Gordon Schanzlin New Vision at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of this clinical trial is to evaluate the safety of Miebo for contact lens wearers. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.