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

Sacsh

Status and phase: Completed; Phase 2

Conditions: Acute Infectious Conjunctivitis (Disorder)

Treatments: Drug: Placebo; Drug: SCH-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05356793

SCH-1001

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Active treatment with SCH-1

Treatment:

Drug: SCH-1

Placebo

Placebo Comparator group

Description:

Vehicle minus active components

Treatment:

Drug: Placebo