The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

Phase 2

Completed

• Conditions: Acute Infectious Conjunctivitis (Disorder)
• Interventions: Drug: SCH-1; Drug: Placebo

• Registration Number: NCT05356793
• Lead Sponsor: Sacsh

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.

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-10
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Primary Completion: 2022-08-13
• Study Completion: 2022-08-13
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	SCH-1	Active treatment with SCH-1
Placebo	Placebo	Vehicle minus active components

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Jacqueline Dauhajre, MD; 🇺🇸 Jackson Heights, New York, United States