FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

NCT00941486 | Terminated Phase 2

• 1 other identifier: FST100-AVC-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 13

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.

Conditions

Acute Adenoviral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.

  1 year

Secondary Outcomes (1)

• Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.

  1 year

Study Arms (2)

FST-100 Ophthalmic Suspension

EXPERIMENTAL

FST-100 (PVP-I 0.4% and dexamethasone 0.1%)

Drug: FST-100 Ophthalmic Suspension

Vehicle

PLACEBO COMPARATOR

Drug: Placebo

Interventions

FST-100 Ophthalmic Suspension DRUG

FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.

FST-100 Ophthalmic Suspension

Placebo DRUG

A regimen of 2 drops 4 times a day while awake for 5 days.

Vehicle

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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").

Sponsors & Collaborators

• Shire: lead

Study Sites (13)

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Colorado Eye Associates

Colorado Springs, Colorado, 80907, United States

Location

Eye Center

Hamden, Connecticut, 06518, United States

Location

The Center for Excellence in Eye

Miami, Florida, 33176, United States

Location

Ocean Ophthalmology

North Miami Beach, Florida, 33179, United States

Location

The Midwest Center for Sight

Des Plaines, Illinois, 60016, United States

Location

Unknown Facility

Hoffman Estates, Illinois, 60169, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

St. Johns Clinic

Springfield, Missouri, 65804, United States

Location

Ophthalmic Consultants PC The New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Unknown Facility

Wantagh, New York, 11793, United States

Location

Unknown Facility

Charlotte, North Carolina, 28204, United States

Location

Columbus Ophthalmology Associates

Columbus, Ohio, 43213, United States

Location

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: June 30, 2009
• Primary Completion: June 30, 2010
• Study Completion: June 30, 2010
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

US (13)