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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05586152
Other study ID # INV-102-CS-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date August 30, 2022
Est. completion date May 2, 2023

Study information

Verified date April 2024
Source Invirsa, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date May 2, 2023
Est. primary completion date May 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
INV-102
INV-102 Ophthalmic Solution
Vehicle
Vehicle Ophthalmic Solution

Locations

Country Name City State
United States iuvo BioScience Rush New York

Sponsors (2)

Lead Sponsor Collaborator
Invirsa, Inc. Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Characterize the safety profile of INV-102 Incidence rate of treatment emergent adverse events (TEAEs) Through study completion (Day 22)
Primary 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 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
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