search
Back to results

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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INV-102
Vehicle
Sponsored by
Invirsa, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring Dry Eye, Keratoconjunctivitis sicca

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • iuvo BioScience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

INV-102 0.1% BID

INV-102 0.25% BID

INV-102 0.7% BID

INV-102 0.7% TID

INV-102 TBD% BID

Vehicle

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Part 1: Characterize the safety profile of INV-102
Incidence rate of treatment emergent adverse events (TEAEs)
Part 2: Evaluate the efficacy of INV-102 in an expanded cohort
Change from Baseline to Day 15 in either the Eye Dryness Score -OR- Eye Discomfort Score from the 7-item DED symptom VAS (specific outcome measure for Part 2 will be chosen based on results from Part 1, Cohorts 1 to 4)

Secondary Outcome Measures

Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score
Change from Baseline to Day 15 in either the Eye Dryness Composite Score -OR- Eye Discomfort Composite Score (outcome measure will be chosen as per Part 2 primary endpoint

Full Information

First Posted
September 19, 2022
Last Updated
June 26, 2023
Sponsor
Invirsa, Inc.
Collaborators
Biomedical Advanced Research and Development Authority
search

1. Study Identification

Unique Protocol Identification Number
NCT05586152
Brief Title
Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease
Official Title
Phase 1/2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Multiple Ascending Dose (Part 1) and Optional Dose Expansion (Part 2) Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate Symptomatic Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invirsa, Inc.
Collaborators
Biomedical Advanced Research and Development Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
Dry Eye, Keratoconjunctivitis sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INV-102 0.1% BID
Arm Type
Experimental
Arm Description
Part 1, Cohort 1: INV-102 ophthalmic solution 0.1% administered twice daily for 2 weeks
Arm Title
INV-102 0.25% BID
Arm Type
Experimental
Arm Description
Part 1, Cohort 2: INV-102 ophthalmic solution 0.25% administered twice daily for 2 weeks
Arm Title
INV-102 0.7% BID
Arm Type
Experimental
Arm Description
Part 1, Cohort 3: INV-102 ophthalmic solution 0.7% administered twice daily for 2 weeks
Arm Title
INV-102 0.7% TID
Arm Type
Experimental
Arm Description
Part 1, Cohort 4: INV-102 ophthalmic solution 0.7% administered three times daily for 2 weeks
Arm Title
INV-102 TBD% BID
Arm Type
Experimental
Arm 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
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
INV-102
Intervention Description
INV-102 Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle Ophthalmic Solution
Primary Outcome Measure Information:
Title
Part 1: Characterize the safety profile of INV-102
Description
Incidence rate of treatment emergent adverse events (TEAEs)
Time Frame
Through study completion (Day 22)
Title
Part 2: Evaluate the efficacy of INV-102 in an expanded cohort
Description
Change from Baseline to Day 15 in either the Eye Dryness Score -OR- Eye Discomfort Score from the 7-item DED symptom VAS (specific outcome measure for Part 2 will be chosen based on results from Part 1, Cohorts 1 to 4)
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score
Description
Change from Baseline to Day 15 in either the Eye Dryness Composite Score -OR- Eye Discomfort Composite Score (outcome measure will be chosen as per Part 2 primary endpoint
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Shalwitz, MD
Organizational Affiliation
Invirsa, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
iuvo BioScience
City
Rush
State/Province
New York
ZIP/Postal Code
14543
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs