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

Acute infectious conjunctivitis is a leading cause of ocular morbidity, epidemic eye infection, lost productivity, patient discomfort and in some cases permanent visual compromise. The infectious agent is frequently viral in origin and frequently bacterial in origin with very little to reliably distinguish one from the other. Concomitant inflammatory damage often occurs and can lead to long term ocular morbidity. No current treatments are capable of treating both viruses and bacteria. Additionally no current combination antibiotic/steroid combinations can safely be administered in suspected viral infections. The objective of this study is to assess the efficacy of SCH1 as a first-line treatment for ocular inflammation and infection in the setting of an acute viral or bacterial conjunctivitis infection.

Inclusion Criteria:

- A documented history of symptoms consistent with infectious conjunctivitis

- Onset of symptoms in most recently affected eye less than 72 hours prior to visit

- At least 18 year of age

- Women of childbearing age must have a negative urine pregnancy test prior to starting the study drug and must not be lactating.

- Subjects or their guardians must be capable of understanding the purpose and risks of the study; able to give informed consent (and assent by pediatric subjects, if required) and to comply with the study requirements

Exclusion Criteria: 

- Conjunctivitis in which the most recently affected eyes had onset of symptoms greater than 72 hours prior to visit

- History of  chronic allergic conjunctivitis, including vernal or atopic keratoconjunctivitis

- Presence of corneal ulcer, endophthalmitis, or other confounding ocular infectious process

- Active herpes virus ocular infection

- Patient with ocular conditions potentially interfering with conjunctival or corneal grading (e.g. chronic conjunctival injection

- Known steroid-responder (steroid-response glaucoma)

- Patient taking topical anti-inflammatory drops on a chronic basis

- Pregnant women

- Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication or compliance with the protocol or return to study visits

- Known allergy to chlorhexidine

Conditions:
• Acute Infectious Conjunctivitis