Blepharitis
Conditions
Brief summary
The objective of this study is to determine the efficacy and safety of Pimecrolimus 0.3% (MR-139) Ophthalmic Ointment.
Detailed description
The study is designed to evaluate Pimecrolimus 0.3% Ophthalmic Ointment in subjects with blepharitis to complete resolution (score = 0 on grading scale of 0-4) for eyelid debris after BID use at Week 6 in the Study Eye.
Interventions
DRUGPimecrolimus 0.3% Ophthalmic Ointment
Pimecrolimus 0.3% Ophthalmic Ointment will be applied twice a day to both eyelid margins.
DRUGPlacebo Ophthalmic Ointment
Placebo will be applied twice a day to both eyelid margins.
Sponsors
Famy Life Sciences, a Viatris Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged ≥ 2 years of age or older at Visit 1, with a diagnosis of blepharitis confirmed by the investigator. 2. Subjects under 18 must able to be examined at the slit lamp (handheld) without systemic anesthesia. 3. A self-reported history of at least 1 previous episode of blepharitis. 4. Adult subjects have provided verbal and written informed consent. For subjects under 16 years of age, a parent or legal guardian of each subject must provide written informed consent and sign the HIPAA form (or equivalent, if applicable), approved by the appropriate Institutional Review Board (IRB)/Ethical Committee (EC). Whenever practical and appropriate per local requirements, a child's assent should also be sought before inclusion into the study. 5. Subjects who have not responded adequately to lid hygiene in the past (self-reported). 6. Have a Corrected Distance Visual Acuity (CDVA) greater than or equal to 0.7 logMar in each eye, assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Subjects may be refracted if needed. 7. Subjects must be able to comply with the requirements of the protocol including the ability to self-administer or receive topical treatment twice a day to their eyelid margins. 8. Be literate and able to complete questionnaires independently, or in the case of pediatric patients, can comprehend the questionnaires with the help of a parent/guardian or interviewer. 9. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at Visit 1 and must be willing to use an adequate method of contraception throughout the study and 30 days from the last application of the study treatment.
Exclusion criteria
1. Subjects who have received a COVID vaccination or recovered from COVID-19 symptoms less than 1 week prior to baseline visit. 2. Subjects with a history of, or active herpetic or neurotrophic keratitis. 3. Subjects who, in the opinion of the investigator, have abnormal eyelid anatomy (other than due to blepharitis) that might adversely affect clinical signs and symptoms, including but not limited to lagophthalmos, malposition of the eyelid or tumor(s) of the eyelid or eyelid margin. 4. Subjects who have received other treatments for blepharitis within 30 days of Visit 1. 5. Subjects with known hypersensitivity to study medications, or to any diagnostic agents to be used in the study. 6. Subjects who are currently enrolled in an investigational drug or device study or have used an investigational drug or device within the 30 days prior to the baseline visit and during the treatment period. 7. Subjects who, in the opinion of the investigator, would be unable to adhere to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Study Drug | 6 weeks | Complete Resolution (score =0 on grading scale 0-4) of eyelid debris. A higher score indicates a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Discomfort Score | 6 weeks | Proportion with at least 50% reduction from baseline in ODS at Week 6. Ocular discomfort is assessed by visual analog scale on a scale from 0-100 where 0 indicates no discomfort and 100 indicates maximum. A higher score indicates a worse outcome. |
| Collarettes | 6 weeks | Proportion of complete resolution for collarettes (score =0 on grading scale 0-4) at Week 6. A higher score indicates a worse outcome. |
| Eyelid Redness | 6 weeks | Proportion of complete resolution (score =0 on grading scale 0-4) for eyelid redness (erythema) at Week 6. A higher score indicates a worse outcome. |
| Blepharitis Symptom Measurement | 6 weeks | Proportion of complete resolution (score =0 on grading scale of 0-3) for the Eye Irritation Symptom on the BLISS at Week 6. A higher score indicates a worse outcome. |
| Eyelid Meibum Character | 6 weeks | Proportion of complete resolution (score = 0 on grading scale 0-24 for upper lid; 0-15 for lower lid) for eyelid meibum character at Week 6. A higher score indicates a worse outcome. |
Countries
United States
Outcome results
None listed