Adenoviral ConjunctivitisPhase 2NCT03749317
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis
A Phase 2 study testing IVIEW-1201 in people with Adenoviral Conjunctivitis, run by IVIEW Therapeutics Inc. at 1 site in India.
Trial summary
A Phase 2, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Placebo in the Treatment of Adenoviral Conjunctivitis Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Adenoviral Conjunctivitis
- What is being tested?
- IVIEW-1201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteIndia
- Study dates
- 20 Feb 2023to 31 Dec 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Ability to voluntarily provide written, signed, and dated to participate in the study.
- Subjects of age 15 and over at Visit 1.
- Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
- Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
- Reported presence of signs and/or symptoms of adenoviral conjunctivitis for ≤ 3 days prior to Visit 1
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- Bulbar conjunctival injection: a grade of >=1 on 0-4 scale of Bulbar Conjunctival Injection Scale
- Watery conjunctival discharge: a grade of >=1 (mild) on a 0-3 Watery Conjunctival Discharge Scale
- Be willing to discontinue contact lens wear for the duration of the study.
- Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
Who cannot join
- Subjects are excluded from the study if any of the following exclusion criteria are met.
- Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
- Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
- Prior enrollment in IVIEW-1201 clinical study.
- Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
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- Have a history of ocular surgical intervention within ≤ 6 months prior to Visit 1 or planned for the period of the study.
- Have a preplanned overnight hospitalization during the period of the study.
- Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
- Have presence of corneal subepithelial infiltrates at Visit 1
- Have at enrollment or within ≤30 days of Visit 1, a clinical presentation more consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or non-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebae, other or parasitic).
- Age under 15.
- Prisoner.
- Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
- Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
- Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
- Presence of significant, active condition in the posterior segment which requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor (VEGF) inhibitors or corticosteroids) and may progress during the study participation period.
- Have used any topical ocular or systemic anti-viral or antibiotics within <= 7 days of enrollment.
- Have used any topical ocular NSAIDs within <=1 day of enrollment.
- Have used any topical ophthalmic steroids in the last <=14 days.
- Have used any systemic corticosteroid agents within <=14 days of Day 1. Stable (initiated ≥30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the peri-ocular area.
- Have used non-corticosteroid immunosuppressive agents within <=14 days of Day 1, oral or topical or both.
- Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
- Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes or cystic fibrosis), that may affect the study parameters, per Investigator's discretion.
- Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (antihepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.
- Within 30 days prior to the first dose of investigational product:
- Have used an investigational product or device, or
- Have been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this IVIEW-sponsored study.
- Pregnant women confirmed with dipstick urine pregnancy testing at Screening and at the final visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of IVIEW-1201 In The Treatment Of Acute Adenoviral Conjunctivitis
A Phase 2, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Placebo in the Treatment of Adenoviral Conjunctivitis
- Conditions
- Adenoviral Conjunctivitis
- Being tested
- IVIEW-1201, Placebo
- Keywords
- IVIEW-1201, Adenoviral Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIEW-1201Drug
Also called Treatment Arm
IVIEW-1201; QID; one drop per eye, four times per day (QID) for 7 days
PlaceboDrug
Also called Placebo Treatment Arm
Placebo drug; QID; one drop per eye, four times per day (QID) for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | IVIEW-1201; four times per day (QID) for 7 days Receives: Drug: IVIEW-1201 |
| Placebo | Placebo comparator | Placebo; four times per day (QID) for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge
Proportion of subjects achieving clinical resolution (zero for conjunctival injection and discharge)
Measured: Day 6 +/- 1 Day
Secondary outcomes (1)
Viral Eradication
Proportion of subjects with negative cell culture-immunofluorescence assay (CC-IFA)
Measured: Day 6 +/- 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start20 Feb 2023
- Primary completion30 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoviral ConjunctivitisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVIEW Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749317
- Sponsor's protocol ID
- IVIEW-1201-01-AIC
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2018
- Last updated
- 15 Oct 2025
- 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 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of IVIEW-1201 In The Treatment Of Acute Adenoviral Conjunctivitis
- ClinicalTrials.gov ID
- NCT03749317
- Acronym / sponsor ID
- IVIEW-1201-01-AIC
- Conditions
- Adenoviral Conjunctivitis
- Keywords
- IVIEW-1201, Adenoviral Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- IVIEW Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Nov 2018 (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.
A Phase 2, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Placebo in the Treatment of Adenoviral Conjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: IVIEW-1201IVIEW-1201; four times per day (QID) for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo; four times per day (QID) for 7 days |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Ability to voluntarily provide written, signed, and dated to participate in the study.
- Subjects of age 15 and over at Visit 1.
- Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
- Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive eye) confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
Key exclusion criteria (29 listed)
- Subjects are excluded from the study if any of the following exclusion criteria are met.
- Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
- Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
- Prior enrollment in IVIEW-1201 clinical study.
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 |
|---|---|---|
| IVIEW-1201Also: Treatment ArmIVIEW-1201; QID; one drop per eye, four times per day (QID) for 7 days | Drug | Treatment |
| PlaceboAlso: Placebo Treatment ArmPlacebo drug; QID; one drop per eye, four times per day (QID) for 7 days | Drug | Placebo |
Primary outcome
Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge
Time frame: Day 6 +/- 1 Day
Proportion of subjects achieving clinical resolution (zero for conjunctival injection and discharge)
1 secondary outcome
Viral Eradication
Time frame: Day 6 +/- 1 Day
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 15 Oct 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IVIEW-1201 in people with Adenoviral Conjunctivitis, run by IVIEW Therapeutics Inc. at 1 site in India.
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 10 inclusion and 29 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 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Clinical resolution by assessment of bulbar conjunctival injection and watery conjunctival discharge (time frame: Day 6 +/- 1 Day). 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 15 Oct 2025.