Status:
TERMINATED
FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis
Lead Sponsor:
Shire
Conditions:
Acute Adenoviral Conjunctivitis
Eligibility:
All Genders
3+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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:
- conjunctival injection/inflammation, and
- conjunctival discharge/exudates.
Exclusion
- 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").
Key Trial Info
Start Date :
June 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00941486
Start Date
June 30 2009
End Date
June 30 2010
Last Update
August 24 2021
Active Locations (13)
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1
Wolstan and Goldberg Eye Associates
Torrance, California, United States, 90505
2
Colorado Eye Associates
Colorado Springs, Colorado, United States, 80907
3
Eye Center
Hamden, Connecticut, United States, 06518
4
The Center for Excellence in Eye
Miami, Florida, United States, 33176