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The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis (SCH1TAIC)

Primary Purpose

Acute Infectious Conjunctivitis (Disorder)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SCH-1
Placebo
Sponsored by
Sacsh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Infectious Conjunctivitis (Disorder) focused on measuring Conjunctivitis, Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jacqueline Dauhajre, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Active treatment with SCH-1

Vehicle minus active components

Outcomes

Primary Outcome Measures

Number of Participants With Clinical Resolution Among Who Received SCH1 or Placebo on 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.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2022
Last Updated
April 10, 2023
Sponsor
Sacsh
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1. Study Identification

Unique Protocol Identification Number
NCT05356793
Brief Title
The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis
Acronym
SCH1TAIC
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 13, 2022 (Actual)
Study Completion Date
August 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sacsh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Infectious Conjunctivitis (Disorder)
Keywords
Conjunctivitis, Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Active treatment with SCH-1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle minus active components
Intervention Type
Drug
Intervention Name(s)
SCH-1
Intervention Description
Novel anti-infective eyedrop
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SCH-1 vehicle minus active components eyedrop
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Resolution Among Who Received SCH1 or Placebo on Day 5
Description
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.
Time Frame
Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ritterband, MD
Organizational Affiliation
Sacsh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacqueline Dauhajre, MD
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

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