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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586152
• Other study ID #: INV-102-CS-001
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

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