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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-30

Study Completion Date

2023-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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INV-102 0.1% Twice daily (BID)

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

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

INV-102 Ophthalmic Solution

INV-102 0.25% BID

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

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

INV-102 Ophthalmic Solution

INV-102 0.7% BID

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

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

INV-102 Ophthalmic Solution

INV-102 0.7% Three times daily (TID)

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

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

INV-102 Ophthalmic Solution

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

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

INV-102 Ophthalmic Solution

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

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle Ophthalmic Solution

Interventions

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INV-102

INV-102 Ophthalmic Solution

Intervention Type DRUG

Vehicle

Vehicle Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subject ≥18 years of age
* Presence of moderate DED in at least one eye

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No