Status:
COMPLETED
The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis
Lead Sponsor:
Sacsh
Conditions:
Acute Infectious Conjunctivitis (Disorder)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05356793
Start Date
September 1 2021
End Date
August 13 2022
Last Update
April 11 2023
Active Locations (1)
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1
Jacqueline Dauhajre, MD
Jackson Heights, New York, United States, 11372