The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05356793

Acronym

SCH1TAIC

Enrollment

Registered

2022-05-02

Start date

2021-03-01

Completion date

2022-03-28

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Infectious Conjunctivitis (Disorder)

Keywords

Conjunctivitis, Eye

Brief 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.

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.

Interventions

DRUGSCH-1

Novel anti-infective eyedrop

DRUGPlacebo

SCH-1 vehicle minus active components eyedrop

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 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.

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

Design outcomes

Primary

Measure	Time frame	Description
Complete Clinical Resolution	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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid Ritterband, MD

Sacsh

Participant flow

Recruitment details

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

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	20 Participants
Age, Categorical Between 18 and 65 years	10 Participants
Age, Continuous	74.2 years STANDARD_DEVIATION 8.8
Conjunctival discharge score of 2 or greater	14 Participants
Conjunctival injection score of 2 or greater	14 Participants
Race and Ethnicity Not Collected	0 Participants
Region of Enrollment United States	30 participants
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 14
other Total, other adverse events	8 / 16	4 / 14
serious Total, serious adverse events	0 / 16	0 / 14

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026