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

• Sponsor: Invirsa, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05586152
• Collaborator: Biomedical Advanced Research and Development Authority (U.S. Fed)
• Enrollment: 72
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 5.1
• Patients Per Site Per Month: 14.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: INV-102; Drug: Vehicle	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Aug 30, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INV-102 0.1% BID Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks	Drug: INV-102; INV-102 Ophthalmic Solution
Experimental: INV-102 0.25% BID Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks	Drug: INV-102; INV-102 Ophthalmic Solution
Experimental: INV-102 0.7% BID Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks	Drug: INV-102; INV-102 Ophthalmic Solution
Experimental: INV-102 0.7% TID Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks	Drug: INV-102; INV-102 Ophthalmic Solution
Experimental: INV-102 TBD% BID 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; INV-102 Ophthalmic Solution
Placebo Comparator: 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	Drug: Vehicle; Vehicle Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

1. Part 1: Characterize the safety profile of INV-102 [Through study completion (Day 22)]

   Incidence rate of treatment emergent adverse events (TEAEs)

2. 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)

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	iuvo BioScience	Rush	New York	United States	14543

Sponsors and Collaborators

• Invirsa, Inc.
• Biomedical Advanced Research and Development Authority

Investigators

• Study Chair: Robert Shalwitz, MD, Invirsa, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Invirsa, Inc.
• ClinicalTrials.gov Identifier: NCT05586152
• Other Study ID Numbers: INV-102-CS-001
• First Posted: Oct 19, 2022
• Last Update Posted: Jan 17, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Invirsa, Inc.: Dry Eye; Keratoconjunctivitis sicca
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases

Study Results

No Results Posted as of Jan 17, 2023