Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease
- Registration Number
- NCT05586152
- Lead Sponsor
- Invirsa, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Healthy male or female subject ≥18 years of age
- Presence of moderate DED in at least one eye
Key
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INV-102 0.7% Three times daily (TID) INV-102 Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks INV-102 TBD% BID INV-102 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 INV-102 0.25% BID INV-102 Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks Vehicle Vehicle 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 INV-102 0.7% BID INV-102 Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks INV-102 0.1% Twice daily (BID) INV-102 Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks
- Primary Outcome Measures
Name Time Method Part 2: Evaluate the efficacy of INV-102 in an expanded cohort Day 15 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)
Part 1: Characterize the safety profile of INV-102 Through study completion (Day 22) Incidence rate of treatment emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score Day 15 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
Trial Locations
- Locations (1)
iuvo BioScience
🇺🇸Rush, New York, United States