Acute Adenoviral ConjunctivitisPhase 2NCT00941486
FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis
A Phase 2 study testing FST-100 Ophthalmic Suspension in people with Acute Adenoviral Conjunctivitis, run by Shire at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Acute Adenoviral Conjunctivitis
- What is being tested?
- FST-100 Ophthalmic Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 13 sitesUnited States
- Study dates
- 30 Jun 2009to 30 Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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").
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Charlotte, North Carolina, 28204
Colorado Eye Associates
Colorado Springs, Colorado, 80907
Columbus Ophthalmology Associates
Columbus, Ohio, 43213
The Midwest Center for Sight
Des Plaines, Illinois, 60016
Eye Center
Hamden, Connecticut, 06518
Study site
Hoffman Estates, Illinois, 60169
Silverstein Eye Centers
Kansas City, Missouri, 64133
The Center for Excellence in Eye
Miami, Florida, 33176
Ophthalmic Consultants PC The New York Eye and Ear Infirmary
New York, New York, 10003
Ocean Ophthalmology
North Miami Beach, Florida, 33179
St. Johns Clinic
Springfield, Missouri, 65804
Wolstan and Goldberg Eye Associates
Torrance, California, 90505
Study site
Wantagh, New York, 11793
About this study
Official title: A Randomized, Masked, Vehicle-controlled Clinical Trial to Assess the Safety and Efficacy of PVP-I (0.4%)/Dexamethasone (0.1%) Ophthalmic Suspension (Foresight Biotherapeutics, Inc) in the Treatment of Acute Adenoviral Conjunctivitis
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
- Being tested
- FST-100 Ophthalmic Suspension, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FST-100 Ophthalmic SuspensionDrug
FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.
PlaceboDrug
A regimen of 2 drops 4 times a day while awake for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| FST-100 Ophthalmic Suspension | Experimental | FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Receives: Drug: FST-100 Ophthalmic Suspension |
| Vehicle | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.
Measured: 1 year
Secondary outcomes (1)
Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study start30 Jun 2009
- Primary completion30 Jun 2010
- Study completion30 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Adenoviral ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941486
- Sponsor's protocol ID
- FST100-AVC-02
- Status last verified
- Aug 2021
- First submitted
- 15 Jul 2009
- Last updated
- 24 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Masked, Vehicle-controlled Clinical Trial to Assess the Safety and Efficacy of PVP-I (0.4%)/Dexamethasone (0.1%) Ophthalmic Suspension (Foresight Biotherapeutics, Inc) in the Treatment of Acute Adenoviral Conjunctivitis
- ClinicalTrials.gov ID
- NCT00941486
- Acronym / sponsor ID
- FST100-AVC-02
- Conditions
- Acute Adenoviral Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2009 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FST-100 Ophthalmic Suspension | Experimental | Drug: FST-100 Ophthalmic SuspensionFST-100 (PVP-I 0.4% and dexamethasone 0.1%) |
| Vehicle | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FST-100 Ophthalmic SuspensionFST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days. | Drug | FST-100 Ophthalmic Suspension |
| PlaceboA regimen of 2 drops 4 times a day while awake for 5 days. | Drug | Vehicle |
Primary outcome
Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.
Time frame: 1 year
1 secondary outcome
Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FST-100 Ophthalmic Suspension in people with Acute Adenoviral Conjunctivitis, run by Shire at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.