NCT06309953CompletedPhase 4
An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
Bausch & Lomb Incorporated7 sites in 1 country99 target enrollmentStarted: February 28, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 99
- Locations
- 7
- Primary Endpoint
- Mean Change From Baseline (CFB) in Dry Eye Symptom Severity at Visit 3
Study Overview
Brief Summary
An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
Detailed Description
The primary objective of this study is to evaluate early outcomes with Miebo treatment in subjects with Dry Eye Disease (DED)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years of age at the time of consent
- •Able to provide written voluntary informed consent
- •The same eye must satisfy the below inclusion criteria (a-e):
- •Subject-reported history of DED in at least 1 eye for at least 6 months prior to Visit 1
- •Tear-film break-up time ≤5 seconds at Visit 1
- •Total corneal fluorescein staining score ≥4 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute scale at Visit 1
- •Total meibomian gland dysfunction score ≥3 (range, 0-15)
- •Unanesthetized Schirmer's test I score ≥5 mm
- •Ocular Surface Disease Index (OSDI) ≥25 at Visit 1
- •Able and willing to follow instructions, including participation in all trial assessments and visits.
Exclusion Criteria
- •Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study
- •Had received Miebo as a prescription or as a study treatment in previous Miebo clinical studies
- •Have any clinically significant ocular surface slit lamp findings at Visit 1 and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters, including:
- •History of eye trauma
- •History of Stevens-Johnson syndrome
- •Active blepharitis or lid margin inflammation
- •DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
- •Abnormal lid anatomy causing incomplete eyelid closure
- •Abnormal cornea shape (keratoconus)
- •Corneal epithelial defect or significant confluent or filaments
- •History of herpetic keratitis
- •Ocular or periocular rosacea
- •Use of any of the following ocular therapies within 60 days prior to Visit 1: Vuity®, any topical ocular steroid treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication
- •Had a LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 1
- •Had received or removed a permanent punctum plug within 3 months (6 months for dissolvable plugs) prior to Visit 1
- •Use of any eye drops (prescription or over-the counter, such as artificial tears or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) within 24 hours prior to Visit 1
- •Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
- •Have worn contact lenses within 1 month prior to Visit 1 or planned wear during the study.
- •Have undergone intraocular surgery or ocular laser surgery within 3 months prior to Visit 1; have undergone refractive surgery within 2 years prior to Visit 1
- •Have active ocular or systemic infection (bacterial, viral, or fungal), including fever.
- •Female subjects who are pregnant, nursing, or planning a pregnancy
- •Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
- •Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
- •Have a known allergy and/or sensitivity to the study treatment
- •Use of any oral medications known to cause ocular drying (eg, antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial
- •Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to Visit 1
- •Have corrected visual acuity (VA) worse than or equal to +0.7 logarithm of the minimum angle of resolution (logMAR), as assessed with Snellen chart at Visit 1
- •Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days prior to Visit 1.
Arms & Interventions
Miebo treatment
Experimental
Intervention: Miebo (Drug)
Outcomes
Primary Outcomes
Mean Change From Baseline (CFB) in Dry Eye Symptom Severity at Visit 3
Time Frame: Change from baseline in VAS at Visit 3 (Day 7 ± 1 day)
Mean change from baseline (CFB) in dry eye symptom severity at Visit 3 (Day 7 ± 1 day) Scale name: Visual Analog Scale Range: min: 0%, max: 100%; 0% corresponds to "none" and 100% corresponds to "worst severity possible" Intrepretation: VAS is a subjective measurement tool that consists of a horizontal assessment line, of 100 mm (10 cm) length where patients place a vertical mark to indicate the level of perceived severity of symptoms. Higher values indicate worse disease severity, lower values indicate better outcome with treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
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