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CompletedNCT05636228Updated Sep 18, 2026

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

A Phase 2 interventional study of INV-102 and Vehicle in Acute Infectious Keratoconjunctivitis, sponsored by Invirsa, Inc.. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Invirsa, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2024, 2 years 2 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Aug 2025.
Phase
Phase 2
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Infectious Keratoconjunctivitis

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Keywords

  • pink eye
  • conjunctivitis
03

In context

Conjunctivitis

85 studies on the registry are indexed under Conjunctivitis; 5 are open to participants now.

This study's enrollment of 93 is below the median of 156 across 63 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Invirsa, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 allergic conjunctivitis as a primary cause of conjunctival hyperemia (bulbar redness) and/or discharge in the opinion of the Investigator
  • Suspected corneal ulcer
  • Ocular topical use within two weeks prior to baseline visit
  • Ocular topical antibiotic use for less than 24 hours or greater than 96 hours of dosing prior to Baseline visit (this does NOT exclude naïve patients or patients that have not taken topical antibiotics)
  • Ocular topical povidone iodine use within 1 week prior to baseline visit
  • Systemic antibiotic use within 2 weeks prior to baseline visit
  • Ocular topical or systemic anti-fungal within 2 weeks prior to baseline visit
  • Ocular topical or systemic anti-viral use within 2 weeks prior to baseline visit
  • Corticosteroid (including but not limited to oral, intranasal, inhaled, topical, etc.) or any use 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 or ocular microsporidia infection
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

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

    INV-102 ophthalmic solution administered for about 1 week

    Drug: INV-102

  • Placebo comparator
    Vehicle TID

    INV-102 ophthalmic solution administered for about 1 week

    Drug: Vehicle

Interventions

  • INV-102 Ophthalmic Solution

  • DrugVehicle

    Vehicle Ophthalmic Solution

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Through End of Treatment (Day 8)

Secondary outcomes

  1. 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

    Time frame: Day 3

07

Study locations

12 sites
  • Global Research Management
    Glendale, California 91204, United States
  • Foothill Eye Institute
    Pasadena, California 91107, United States
  • Shettle Eye Research
    Largo, Florida 33773, United States
  • D & H National Research Centers, INC
    Miami, Florida 33155, United States
  • My Community Research Center, Inc.
    Miami, Florida 33155, United States
  • Quantum Clinical Trials
    Miami Beach, Florida 33140, United States
  • Kannarr Eye Center
    Pittsburg, Kansas 66762, United States
  • Oculos Clinical Research
    Garner, North Carolina 27529, United States
  • Athens Eye Care
    Athens, Ohio 45701, United States
  • Revolution Research/ Lake Travis Eye and Laser Center
    Lakeway, Texas 78738, United States
  • King Chulalongkorn Memorial Hospital
    Bangkok, 10330, Thailand
  • Mahidol university
    Bangkok, 10400, Thailand
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Aug 2024, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2022
First posted
Dec 5, 2022
StartActual
Jun 9, 2023
Primary completionActual
Aug 22, 2024
CompletionActual
Aug 22, 2024
Results delay requested
Aug 20, 2025
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05636228
Lead sponsor
Invirsa, Inc.
Collaborators
Biomedical Advanced Research and Development Authority
Responsible party
Sponsor
First posted
Dec 5, 2022
Start date
Jun 9, 2023
Primary completion
Aug 22, 2024
Completion
Aug 22, 2024
Last update
Sep 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: INV-102

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