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Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis

Primary Purpose

Acute Infectious Keratoconjunctivitis

Status
Suspended
Phase
Phase 2
Locations
Thailand
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 Acute Infectious Keratoconjunctivitis focused on measuring pink eye, conjunctivitis

Eligibility Criteria

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

Inclusion Criteria: Male or female patient ≥ 18 years of age A clinical diagnosis of AIK with a minimum of a 2+ (moderate) conjunctival hyperemia and a minimum of 1+ (mild) discharge (whether it be watery or purulent) in at least one eye Exclusion Criteria: Untreated keratoconjunctivitis of any type that has lasted 96 consecutive hours or more prior to baseline visit Infectious blepharitis as the primary cause of ocular hyperemia and discharge in the opinion of the investigator (Note: If the blepharitis is secondary to the conjunctivitis, the patient can be included) Suspected corneal ulcer Ocular topical steroid use within two weeks prior to baseline visit Ocular topical antibiotic use for less than 24 hours of dosing prior to baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics) Ocular topical antibiotic use greater than 96 hours prior to baseline visit Ocular topical povidone iodine use within one week prior to baseline visit Systemic antibiotic use within two weeks prior to baseline visit Ocular topical or systemic anti-fungal within two weeks prior to baseline visit Ocular topical or systemic anti-viral use within two weeks prior to baseline visit Systemic steroid or any immunosuppressant within 30 days prior to baseline visit On current treatment for herpes keratitis (evidence of herpes keratitis and/or ocular dendrites can be included) Known or suspected ocular fungal infection Suspected ocular microsporidia infection

Sites / Locations

  • King Chulalongkorn Memorial Hospital
  • Mahidol university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

INV-102 0.7% Three Times per Day (TID)

Vehicle TID

Arm Description

INV-102 ophthalmic solution administered for about 1 week

INV-102 ophthalmic solution administered for about 1 week

Outcomes

Primary Outcome Measures

To Evaluate the Change in Combined Clinical Score
To evaluate the efficacy of INV-102 compared to vehicle control in reducing Combined Clinical Score (bulbar hyperemia plus conjunctival discharge) in patients with AIK. Conjunctival hyperemia will be rated by using the modified version of Cornea and Contact Lens Research Unit grading scale for bulbar redness, which ranges from 0 (none) to 4 points (very severe). Conjunctival discharge will be assessed using the chart below from Schwab and Friedlander (2002) to score conjunctival discharge from 0 (absent/normal) to 3 (severe).

Secondary Outcome Measures

To Evaluate the Percent of participants requiring rescue
To evaluate the percent of patients requiring rescue therapy from Day 3 in the INV-102 arm compared to vehicle control

Full Information

First Posted
November 23, 2022
Last Updated
August 31, 2023
Sponsor
Invirsa, Inc.
Collaborators
Biomedical Advanced Research and Development Authority
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1. Study Identification

Unique Protocol Identification Number
NCT05636228
Brief Title
Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis
Official Title
Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Patients With Acute Infectious Keratoconjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Study will be closed in Thailand and opened in the USA.
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

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 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Infectious Keratoconjunctivitis
Keywords
pink eye, conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INV-102 0.7% Three Times per Day (TID)
Arm Type
Experimental
Arm Description
INV-102 ophthalmic solution administered for about 1 week
Arm Title
Vehicle TID
Arm Type
Placebo Comparator
Arm Description
INV-102 ophthalmic solution administered for about 1 week
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
To Evaluate the Change in Combined Clinical Score
Description
To evaluate the efficacy of INV-102 compared to vehicle control in reducing Combined Clinical Score (bulbar hyperemia plus conjunctival discharge) in patients with AIK. Conjunctival hyperemia will be rated by using the modified version of Cornea and Contact Lens Research Unit grading scale for bulbar redness, which ranges from 0 (none) to 4 points (very severe). Conjunctival discharge will be assessed using the chart below from Schwab and Friedlander (2002) to score conjunctival discharge from 0 (absent/normal) to 3 (severe).
Time Frame
Through End of Treatment (Day 8)
Secondary Outcome Measure Information:
Title
To Evaluate the Percent of participants requiring rescue
Description
To evaluate the percent of patients requiring rescue therapy from Day 3 in the INV-102 arm compared to vehicle control
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patient ≥ 18 years of age A clinical diagnosis of AIK with a minimum of a 2+ (moderate) conjunctival hyperemia and a minimum of 1+ (mild) discharge (whether it be watery or purulent) in at least one eye Exclusion Criteria: Untreated keratoconjunctivitis of any type that has lasted 96 consecutive hours or more prior to baseline visit Infectious blepharitis as the primary cause of ocular hyperemia and discharge in the opinion of the investigator (Note: If the blepharitis is secondary to the conjunctivitis, the patient can be included) Suspected corneal ulcer Ocular topical steroid use within two weeks prior to baseline visit Ocular topical antibiotic use for less than 24 hours of dosing prior to baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics) Ocular topical antibiotic use greater than 96 hours prior to baseline visit Ocular topical povidone iodine use within one week prior to baseline visit Systemic antibiotic use within two weeks prior to baseline visit Ocular topical or systemic anti-fungal within two weeks prior to baseline visit Ocular topical or systemic anti-viral use within two weeks prior to baseline visit Systemic steroid or any immunosuppressant within 30 days prior to baseline visit On current treatment for herpes keratitis (evidence of herpes keratitis and/or ocular dendrites can be included) Known or suspected ocular fungal infection Suspected ocular microsporidia infection
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Mahidol university
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis

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