Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe 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

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-27

Study Completion Date

2024-07-03

Brief Summary

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Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe 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

INV-102 0.7% ophthalmic solution administered for 4 weeks (twice daily \[BID\] for 2 weeks, then once daily \[QD\] for an additional 2 weeks)

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

INV-102 Ophthalmic Solution

Vehicle

Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 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

* Subjects ≥18 and \<75 years of age
* Presence of moderate to severe dry eye disease (DED) in at least one eye

Exclusion Criteria

* Presently using prescription eyedrops, except those used for dry eye disease, which must be discontinued 4 weeks prior
* Use of over-the-counter (OTC) eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
* History or evidence of ocular infection within the previous 30 days
* Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
* Allergic conjunctivitis requiring treatment within 30 days
* Unable to discontinue contact lens wear for 2 weeks prior and for the duration of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No