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

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: Vehicle; Drug: INV-102

• Registration Number: NCT06370039
• Lead Sponsor: Invirsa, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-27
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Status Verified: 2024-07
• Primary Completion: 2024-07-03
• Study Completion: 2024-07-03
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

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

Key

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks)
INV-102	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)

Primary Outcome Measures

Name	Time	Method
Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale	Baseline to Day 29	Corneal fluorescein staining assessment will be performed using the NEI grading system to score each of 5 corneal zones (central, superior, lateral, medial, inferior) on a 0 to 3 scale (with a total score of 0 to 15). Higher scores indicate more corneal damage.

Secondary Outcome Measures

Name	Time	Method
Percentage of eyes with complete clearing of central corneal fluorescein staining	Baseline to Day 29

Trial Locations

Locations (1)

iuvo BioScience; 🇺🇸 Rush, New York, United States