CompletedNCT05356793SCH1TAICUpdated Apr 14, 2026Results posted

The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

A Phase 2 interventional study of SCH-1 and Placebo in Acute Infectious Conjunctivitis (Disorder), sponsored by Sacsh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Sacsh · Phase 2, Interventional, and Treatment

From the registry’s dates

Registered 1 year 1 month after the study started (first participant enrolled Mar 2021, registered Apr 2022).

Phase: Phase 2
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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.

Conditions studied

Acute Infectious Conjunctivitis (Disorder)

Browse trials for

Conjunctivitis 85

Keywords

Conjunctivitis
Eye

In context

Conjunctivitis

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

This study's enrollment of 30 is below the median of 156 across 63 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

This is the only study on the registry with Sacsh as lead sponsor.

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

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

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 .
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.

Exclusion criteria

Exclusion Criteria:

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 glaucoma responders
Active herpes ocular infection
Pregnant women
Known allergy to chlorhexidine

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 30 participants (actual)

Study arms

Experimental
Treatment
Active treatment with SCH-1
Drug: SCH-1
Placebo comparator
Placebo
Vehicle minus active components
Drug: Placebo

Interventions

DrugSCH-1
Novel anti-infective eyedrop
DrugPlacebo
SCH-1 vehicle minus active components eyedrop

What researchers measure

Primary outcomes

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).
Time frame: Day 5

Results

Posted Apr 14, 2026

Limitations and caveats

Caveat: While designed to evaluate efficacy in any type of infectious conjunctivitis, the majority of patients recruited turned out to have viral conjunctivitis.

Participant flow

March 1, 2021 to March 28, 2022, Single Private Practice Clinical Site

Participant flow — Overall Study
Milestone	Treatment	Placebo
Started	16	14
Completed	16	14
Not completed	0	0

Outcome measures

PrimaryComplete 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).

Time frame:: Day 5
Reported as:: Count of participants · Participants

Complete Clinical Resolution
Participants	Treatment	Placebo
Complete Clinical Resolution	9	0

Adverse events

Collected over 5 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment	0/16 (0%)	0/16 (0%)	8/16 (50%)
Placebo	0/14 (0%)	0/14 (0%)	4/14 (28.6%)

Most frequent other events

Most frequent other events
Event	Treatment	Placebo
Discomfort upon instillation of dropEye disorders	8/16	4/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Treatment	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	2	8	10
>=65 years	14	6	20

Age, Continuous
Age, Continuous(years)	Treatment	Placebo	Total
Mean	74.2 ± 8.8	66.1 ± 7.4	70.4 ± 9.0

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment	Placebo	Total
Female	13	8	21
Male	3	6	9

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Treatment	Placebo	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Treatment	Placebo	Total
United States	16	14	30

Conjunctival injection score of 2 or greater
Conjunctival injection score of 2 or greater(Participants)	Treatment	Placebo	Total
Count of participants	16	14	30

Conjunctival discharge score of 2 or greater
Conjunctival discharge score of 2 or greater(Participants)	Treatment	Placebo	Total
Count of participants	16	14	30

Study locations

1 site

Jacqueline Dauhajre, MD
Jackson Heights, New York 11372, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Apr 1, 2026
Informed consent form ↗ · Aug 27, 2020

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Mar 2022, 12 months.

Results were first posted in Apr 2026, 4 years after primary completion.

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

Registered: Apr 10, 2022
First posted: May 2, 2022
StartActual: Mar 1, 2021
Primary completionActual: Mar 28, 2022
CompletionActual: Mar 28, 2022
Results first posted: Apr 14, 2026
Last update: Apr 14, 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 Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05356793
Lead sponsor: Sacsh
Responsible party: Sponsor
First posted: May 2, 2022
Start date: Mar 1, 2021
Primary completion: Mar 28, 2022
Completion: Mar 28, 2022
Results posted: Apr 14, 2026
Last update: Apr 14, 2026

Study contacts

David Ritterband, MD

principal investigator · Sacsh

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Discussion

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