The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

NCT ID: NCT05356793

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-08-13

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.

Conditions

Acute Infectious Conjunctivitis (Disorder)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment

Active treatment with SCH-1

Group Type: EXPERIMENTAL

SCH-1

Intervention Type: DRUG

Novel anti-infective eyedrop

Placebo

Vehicle minus active components

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

SCH-1 vehicle minus active components eyedrop

Interventions

SCH-1

Novel anti-infective eyedrop

Intervention Type: DRUG

Placebo

SCH-1 vehicle minus active components eyedrop

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sacsh

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ritterband, MD

Role: PRINCIPAL_INVESTIGATOR

Sacsh

Locations

Jacqueline Dauhajre, MD

Jackson Heights, New York, United States

Countries

United States

Other Identifiers

SCH-1001

Identifier Type: -

Identifier Source: org_study_id