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OpenTrials
Completed

NCT Number: NCT05356793

The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jacqueline Dauhajre, MD

Jackson Heights, New York, 11372, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCH-1

Drug

Novel anti-infective eyedrop

Placebo

Drug

SCH-1 vehicle minus active components eyedrop

Primary outcomes

  1. Complete Clinical Resolution

    Time frame: Day 5

    Clinical score of 0 (zero) for both Conjunctival Injection (Minimum score: 0, maximum score: 3, 0 is best outcome) and Conjunctival Discharge (minimum score: 0, maximum score 3, 0 is best outcome).

Sponsors and collaborators

Lead sponsor

Sacsh

Industry

Registry information

Official study title

A Double-Masked, Placebo-Controlled, Randomized, Phase II Clinical Trial To Assess The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

Acronym: SCH1TAIC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 2, 2022
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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