Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease

Study Overview
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Brief Summary
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Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic dry eye disease.

Official Title
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Phase 1/2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Multiple Ascending Dose (Part 1) and Optional Dose Expansion (Part 2) Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate Symptomatic Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: INV-102
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy male or female subject ≥18 years of age Presence of moderate DED in at least one eye Key Exclusion Criteria: Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing External eye disease except primary DED Systemic disease associated with DED History or evidence of ocular infection within the previous 30 days History or evidence of ocular herpes simplex or ocular herpes zoster Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INV-102 0.1% BID<br>Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks | Drug: INV-102<br>* INV-102 Ophthalmic Solution<br>|
| Experimental: INV-102 0.25% BID<br>Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks | Drug: INV-102<br>* INV-102 Ophthalmic Solution<br>|
| Experimental: INV-102 0.7% BID<br>Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks | Drug: INV-102<br>* INV-102 Ophthalmic Solution<br>|
| Experimental: INV-102 0.7% TID<br>Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks | Drug: INV-102<br>* INV-102 Ophthalmic Solution<br>|
| Experimental: INV-102 TBD% BID<br>Part 2, Cohort 5: INV-102 ophthalmic solution administered for 2 weeks using a dose based on the results from Part 1, Cohorts 1 to 4 | Drug: INV-102<br>* INV-102 Ophthalmic Solution<br>|
| Placebo Comparator: Vehicle<br>Part 1 (Cohorts 1-4) and Part 2 (Cohort 5): Vehicle ophthalmic solution administered two or three times daily (dependent on the cohort and the frequency of dosing of INV-102) for 2 weeks | Drug: Vehicle<br>* Vehicle Ophthalmic Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Characterize the safety profile of INV-102 | Incidence rate of treatment emergent adverse events (TEAEs) | Through study completion (Day 22) | 
| Part 2: Evaluate the efficacy of INV-102 in an expanded cohort | Change from Baseline to Day 15 in either the Eye Dryness Score -OR- Eye Discomfort Score from the 7-item DED symptom VAS (specific outcome measure for Part 2 will be chosen based on results from Part 1, Cohorts 1 to 4) | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score | Change from Baseline to Day 15 in either the Eye Dryness Composite Score -OR- Eye Discomfort Composite Score (outcome measure will be chosen as per Part 2 primary endpoint | Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Keratoconjunctivitis sicca