Acute Infectious Conjunctivitis (Disorder)Phase 2SCH1TAICNCT05356793
The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis
A Phase 2 study testing SCH-1 in people with Acute Infectious Conjunctivitis (Disorder), run by Sacsh at 1 site in United States.
Trial summary
The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Infectious Conjunctivitis (Disorder)
- What is being tested?
- SCH-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 28 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Conjunctivitis (as defined below) within 72 hours of initial ocular symptoms.
- At least 18 years of age.
- Subjects capable of understanding the purpose and risks of the study, and able to give informed consent.
- Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis- 1) bulbar conjunctival injection and 2) conjunctival discharge/exudates.
- A three-point rating scale (0=absent, 1=mild, 2=moderate, 3=severe) will be employed to grade conjunctival discharge/exudates.
- All patients will require a rating of 1(mild) or greater for conjunctival discharge/exudates.
- Patients will require a rating of 1 (mild) for bulbar conjunctival injection.
Who cannot join
- Conjunctivitis greater than 72 hours after initial ocular symptoms
- Corneal ulcer, endophthalmitis, or any other confounding infection of the eye
- Patients taking topical anti-inflammatory medications on a chronic basis
- Known steroid glaucoma responders
- Active herpes ocular infection
- Pregnant women
- Known allergy to chlorhexidine
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacqueline Dauhajre, MD
Jackson Heights, New York, 11372
About this study
Official title: A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis
The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis.
Read the detailed description
This is a Phase II single-center, double-masked, placebo controlled, randomized study of SCH1 for the treatment of infectious conjunctivitis. Approximately 30 subjects will be enrolled, who will be randomized in a 1:1 ratio between SCH1and placebo. Subjects will be assessed at day 1, day 3, and day 5 for efficacy and safety.
- Being tested
- SCH-1, Placebo
- Keywords
- Conjunctivitis, Eye
- Medical subject headings
- Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH-1Drug
Novel anti-infective eyedrop
PlaceboDrug
SCH-1 vehicle minus active components eyedrop
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Active treatment with SCH-1 Receives: Drug: SCH-1 |
| Placebo | Placebo comparator | Vehicle minus active components Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clinical Resolution
Clinical score of 0 (zero) for both Conjunctival Injection (Minimum score: 0, maximum score: 3, 0 is best outcome) and Conjunctival Discharge (minimum score: 0, maximum score 3, 0 is best outcome).
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Mar 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Infectious Conjunctivitis (Disorder)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sacsh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Ritterband, MD, Principal investigator, Sacsh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356793
- Sponsor's protocol ID
- SCH-1001
- Acronym
- SCH1TAIC
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2022
- Last updated
- 14 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. 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 SCH1 In The Treatment Of Acute Infectious Conjunctivitis
- ClinicalTrials.gov ID
- NCT05356793
- Acronym / sponsor ID
- SCH1TAIC / SCH-1001
- Keywords
- Conjunctivitis, Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SacshIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Posted 14 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis.
Detailed description
This is a Phase II single-center, double-masked, placebo controlled, randomized study of SCH1 for the treatment of infectious conjunctivitis. Approximately 30 subjects will be enrolled, who will be randomized in a 1:1 ratio between SCH1and placebo. Subjects will be assessed at day 1, day 3, and day 5 for efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: SCH-1Active treatment with SCH-1 |
| Placebo | Placebo comparator | Drug: PlaceboVehicle minus active components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Conjunctivitis (as defined below) within 72 hours of initial ocular symptoms.
- At least 18 years of age.
- Subjects capable of understanding the purpose and risks of the study, and able to give informed consent.
- Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis- 1) bulbar conjunctival injection and 2) conjunctival discharge/exudates.
- A three-point rating scale (0=absent, 1=mild, 2=moderate, 3=severe) will be employed to grade conjunctival discharge/exudates.
Key exclusion criteria (7 listed)
- Conjunctivitis greater than 72 hours after initial ocular symptoms
- Corneal ulcer, endophthalmitis, or any other confounding infection of the eye
- Patients taking topical anti-inflammatory medications on a chronic basis
- Known steroid glaucoma responders
- Active herpes ocular infection
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 |
|---|---|---|
| SCH-1Novel anti-infective eyedrop | Drug | Treatment |
| PlaceboSCH-1 vehicle minus active components eyedrop | Drug | Placebo |
Primary outcome
Complete Clinical Resolution
Time frame: Day 5
Clinical score of 0 (zero) for both Conjunctival Injection (Minimum score: 0, maximum score: 3, 0 is best outcome) and Conjunctival Discharge (minimum score: 0, maximum score 3, 0 is best outcome).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
David Ritterband, MD principal investigator
Sacsh
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 SCH-1 in people with Acute Infectious Conjunctivitis (Disorder), run by Sacsh at 1 site in United States.
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 7 inclusion and 7 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 14 Apr 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Clinical Resolution (time frame: Day 5). 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 14 Apr 2026.