The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

Study Overview
=================
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.

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

Conditions
-----------------
Acute Infectious Conjunctivitis (Disorder)

Intervention / Treatment
-----------------
* Drug: SCH-1
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Active treatment with SCH-1 | Drug: SCH-1<br>* Novel anti-infective eyedrop<br>|
| Placebo Comparator: Placebo<br>Vehicle minus active components | Drug: Placebo<br>* SCH-1 vehicle minus active components eyedrop<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Conjunctivitis, Eye