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

April 22, 2024 updated by: Invirsa, Inc.

Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate to Severe Dry Eye Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Rush, New York, United States, 14543
        • Recruiting
        • iuvo BioScience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: INV-102
INV-102 Ophthalmic Solution
Placebo Comparator: Vehicle
Vehicle ophthalmic solution administered for 4 weeks (BID for 2 weeks, then QD for an additional 2 weeks)
Drug: Vehicle
Vehicle Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale
Time Frame: 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.
Baseline to Day 29

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of eyes with complete clearing of central corneal fluorescein staining
Time Frame: Baseline to Day 29
Baseline to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Invirsa, Inc.

Investigators

  • Study Chair: Robert Shalwitz, MD, Invirsa, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INV-102-CS-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Disease

Clinical Trials on INV-102

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe