SCH1TAIC: The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

Sponsor

Sacsh (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05356793

Collaborator

(none)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Infectious Conjunctivitis (Disorder)	Drug: SCH-1 Drug: Placebo	Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Active treatment with SCH-1	Drug: SCH-1 Novel anti-infective eyedrop
Placebo Comparator: Placebo Vehicle minus active components	Drug: Placebo SCH-1 vehicle minus active components eyedrop

Arm

Intervention/Treatment

Experimental: Treatment

Active treatment with SCH-1

Drug: SCH-1

Novel anti-infective eyedrop

Placebo Comparator: Placebo

Vehicle minus active components

Drug: Placebo

SCH-1 vehicle minus active components eyedrop

Outcome Measures

Primary Outcome Measures

Number of Participants With Clinical Resolution Among Who Received SCH1 or Placebo on Day 5 [Day 5]
Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 3 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SCH1 and placebo reporting groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jacqueline Dauhajre, MD	Jackson Heights	New York	United States	11372

Sponsors and Collaborators

Sacsh

Investigators

Principal Investigator: David Ritterband, MD, Sacsh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sacsh

ClinicalTrials.gov Identifier:

NCT05356793

Other Study ID Numbers:

SCH-1001

First Posted:

May 2, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sacsh

Conjunctivitis

Eye

Additional relevant MeSH terms:

Communicable Diseases

Infections

Conjunctivitis

Study Results

No Results Posted as of May 2, 2022