Safety and Efficacy of Licaminlimab Ophthalmic Suspension for the Treatment of Signs and Symptoms of Dry Eye Disease
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of Licaminlimab for the treatment of signs of dry eye disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
A Multi-center, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Licaminlimab for the Treatment of Signs and Symptoms of Dry Eye Disease
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment arm artificial tears three times daily (TID) for 2 weeks then Licaminlimab ophthalmic suspension 60 mg/mL three times daily (TID) for 6 weeks and a 2-week follow-up. |
Biological: Licaminlimab ophthalmic suspension 60 mg/mL
Screening phase, an artificial tears run-in phase, a 6-week treatment phase, and a 2-week follow-up.
|
| Placebo Comparator: Placebo arm artificial tears three times daily (TID) for 2 weeks then placebo (vehicle of Licaminlimab ophthalmic suspension) three times daily (TID) for 6 weeks and a 2-week follow-up. |
Other: placebo (vehicle of Licaminlimab ophthalmic suspension)
Screening phase, an artificial tears run-in phase, a 6-week treatment phase, and a 2-week follow-up.
|
Outcome Measures
Primary Outcome Measures
- safety of Licaminlimab for the treatment of signs of dry eye disease. [Visit 6 (Day 57)]
Analysis of adverse events (AEs) coded using the MedDRA dictionary.
- efficacy of Licaminlimab for the treatment of signs of dry eye disease. [Visit 5 (Day 43)]
Measure of total corneal staining expressed in percentage
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be at least 18 years of age.
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Provide written informed consent.
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Be willing and able to comply with all study procedures.
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Have a history of dry eye disease in both eyes for at least 6 months prior to Visit 1.
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Have a history of using artificial tears, gels, lubricants, or rewetting drops regularly for dry eye symptoms within 6 months of Visit 1.
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Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1.
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Report a score of ≥ 2 according to the ocular discomfort & 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2.
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Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2.
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Have a corneal fluorescein staining score of ≥ 2 in at least one region in one eye at Visits 1 and 2 and a central corneal staining score ≥ 1 in the same eye.
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Have a conjunctival redness score ≥ 1 in at least one eye at Visits 1 and 2 pre-controlled adverse environment (pre-CAE®).
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Demonstrate in the same eye(s) a response to the controlled adverse environment (CAE®) at Visits 1 and 2 as defined by:
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Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE® exposure.
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Reporting an Ocular Discomfort score ≥3 at 2 or more consecutive time points in at least one eye during CAE® exposure (if a subject has an Ocular Discomfort rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating of 4 for two consecutive measurements for that eye). Note: a subject cannot have an Ocular Discomfort score of 4 at time = 0).
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Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10, and 11 above.
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A negative urine pregnancy test if female of childbearing potential (those who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post- menopausal [12 months after last menses]) and must use adequate birth control through the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.
Exclusion Criteria:
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Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters.
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Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1 or Visit 2.
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Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study.
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Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months, or have any ocular surgical procedure scheduled to be conducted during the study period.
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Have used Restasis®, Xiidra®, Cequa®, Eysuvis®, or Tyrvaya® within 45 days of Visit 1 or anticipate their use during the study period.
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Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period.
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Have had any laser procedures (e.g. yttrium aluminium garnet (YAG) capsulotomy) in the past 3 months.
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Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.
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Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); the respective wash-out periods are required for the following medications:
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Ocular, oral or nasal antihistamines: 72 hours prior to Visit 1 and during the study
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Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period
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Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1 and during the study
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Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study
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All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1 and during the study
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Have had prior administration of systemic biologic anti-cytokines including TNFαinhibitors or immunosuppressive therapy within 2 months of Visit 1 or anticipate any such event at any time during the study period.
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Have an uncontrolled systemic disease.
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Be a woman who is pregnant, nursing, or planning a pregnancy.
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Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 5 (or early termination visit) if of childbearing potential. Non-childbearing potential is defined as a woman who is permanently sterilized (e.g., bilateral tubal ligation, hysterectomy or bilateral oophorectomy), or is post-menopausal (without menses for 12 consecutive months).
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Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study.
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Have a known allergy and/or sensitivity to the test article or its components.
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Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
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Have used an investigational drug or device within 30 days of Visit 1.
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Be unable or unwilling to follow instructions, including participation in all study assessments and visits.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Oculis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LC-201