FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

Shire

Status and phase

Terminated

Phase 2

Conditions

Acute Adenoviral Conjunctivitis

Treatments

Drug: Placebo

Drug: FST-100 Ophthalmic Suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT00941486

FST100-AVC-02

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

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").