Acute Infectious KeratoconjunctivitisPhase 2NCT05636228
Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis
A Phase 2 study testing INV-102 in people with Acute Infectious Keratoconjunctivitis, run by Invirsa, Inc. at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Infectious Keratoconjunctivitis
- What is being tested?
- INV-102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 9 Jun 2023to 22 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 steroid 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)
Show all 13Show fewer
- 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 immunosuppressant 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
Athens Eye Care
Athens, Ohio, 45701
Oculos Clinical Research
Garner, North Carolina, 27529
Global Research Management
Glendale, California, 91204
Revolution Research/ Lake Travis Eye and Laser Center
Lakeway, Texas, 78738
Shettle Eye Research
Largo, Florida, 33773
D & H National Research Centers, INC
Miami, Florida, 33155
My Community Research Center, Inc.
Miami, Florida, 33155
Quantum Clinical Trials
Miami Beach, Florida, 33140
Foothill Eye Institute
Pasadena, California, 91107
Kannarr Eye Center
Pittsburg, Kansas, 66762
Thailand2 sites
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Mahidol university
Bangkok, 10400
About this study
Official title: Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Patients With Acute Infectious Keratoconjunctivitis
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.
- Conditions
- Acute Infectious Keratoconjunctivitis
- Being tested
- INV-102, Vehicle
- Keywords
- pink eye, conjunctivitis
- Medical subject headings
- Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-102Drug
INV-102 Ophthalmic Solution
VehicleDrug
Vehicle Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| INV-102 0.7% Three Times per Day (TID) | Experimental | INV-102 ophthalmic solution administered for about 1 week Receives: Drug: INV-102 |
| Vehicle TID | Placebo comparator | INV-102 ophthalmic solution administered for about 1 week Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start9 Jun 2023
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Infectious KeratoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invirsa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636228
- Sponsor's protocol ID
- INV-102-CS-002
- Other IDs
- 75A50120C00171
- Status last verified
- Sep 2026
- First submitted
- 23 Nov 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study of INV-102 Ophthalmic Solution in Patients With Acute Infectious Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT05636228
- Acronym / sponsor ID
- INV-102-CS-002
- Conditions
- Acute Infectious Keratoconjunctivitis
- Keywords
- pink eye, conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Invirsa, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INV-102 0.7% Three Times per Day (TID) | Experimental | Drug: INV-102INV-102 ophthalmic solution administered for about 1 week |
| Vehicle TID | Placebo comparator | Drug: VehicleINV-102 ophthalmic solution administered for about 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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 steroid use within two weeks prior to baseline visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INV-102INV-102 Ophthalmic Solution | Drug | INV-102 0.7% Three Times per Day (TID) |
| VehicleVehicle Ophthalmic Solution | Drug | Vehicle TID |
Primary outcome
To Evaluate the Change in Combined Clinical Score
Time frame: Through End of Treatment (Day 8)
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).
1 secondary outcome
To Evaluate the Percent of participants requiring rescue
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INV-102 in people with Acute Infectious Keratoconjunctivitis, run by Invirsa, Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate the Change in Combined Clinical Score (time frame: Through End of Treatment (Day 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.