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

Invirsa

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: Vehicle; Drug: INV-102

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT05586152

INV-102-CS-001

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 6 patient groups, including a placebo group

INV-102 0.1% Twice daily (BID)

Experimental group

Description:

Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks

Treatment:

Drug: INV-102

INV-102 0.25% BID

Experimental group

Description:

Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks

Treatment:

Drug: INV-102

INV-102 0.7% BID

Experimental group

Description:

Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks

Treatment:

Drug: INV-102

INV-102 0.7% Three times daily (TID)

Experimental group

Description:

Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks

Treatment:

Drug: INV-102

INV-102 TBD% BID

Experimental group

Description:

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

Treatment:

Drug: INV-102

Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle