FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

• Status: Terminated
• Trial end date: 2010-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the efficacy of FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge.

• Clinical suspicion of adenoviral etiology.

• At least three (3) years of age.

• Subjects or their guardians 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. conjunctival injection/inflammation, and

2. conjunctival discharge/exudates.

Exclusion Criteria:

• Conjunctivitis longer than 7 days after initial ocular symptoms.

• Corneal ulcer, endophthalmitis, or any other confounding infection of the eye.

• Patients taking ocular anti-inflammatory medications on a chronic basis.

• Active herpes ocular infection.

• Known or suspected pregnancy.

• Known allergy to PVP-I.

• Known allergy to dexamethasone.

• Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders").