Allergic ConjunctivitisPhase 3NCT00364091
Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis
A Phase 3 study testing R89674 0.025% ophthalmic solution in people with Allergic Conjunctivitis, run by Vistakon Pharmaceuticals at 6 sites in United States.
Trial summary
The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- R89674 0.025% ophthalmic solution
- How many people
- 365 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2006to Oct 2006
- Phase
- Phase 3
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- history of positive diagnostic test for ragweed within the past 2 years;
- positive bilateral response to ragweed as induced by conjunctival allergen challenge
Who cannot join
- ocular infection;
- history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
- moderate to severe asthma;
- dry eye syndrome;
- history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
- pregnancy or lactation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Charlotte, North Carolina
Study site
Creve Coeur, Missouri
Study site
Louisville, Kentucky
Study site
Memphis, Tennessee
Study site
North Andover, Massachusetts
Study site
Philadelphia, Pennsylvania
About this study
Official title: A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis
The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis
- Conditions
- Allergic Conjunctivitis
- Being tested
- R89674 0.025% ophthalmic solution
- Keywords
- allergic conjunctivitis, ophthalmology, multicenter, controlled
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R89674 0.025% ophthalmic solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itching and redness scores at defined timepoints
Secondary outcomes (1)
QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vistakon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reza Haque, MD, Study director, Vistakon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364091
- Sponsor's protocol ID
- 06-003-09
- Status last verified
- Sep 2011
- First submitted
- 11 Aug 2006
- Last updated
- 27 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT00364091
- Acronym / sponsor ID
- 06-003-09
- Conditions
- Allergic Conjunctivitis
- Keywords
- allergic conjunctivitis, ophthalmology, multicenter, controlled
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Oct 2006 (actual)
- First posted
- 15 Aug 2006 (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 purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- history of positive diagnostic test for ragweed within the past 2 years;
- positive bilateral response to ragweed as induced by conjunctival allergen challenge
Key exclusion criteria (6 listed)
- ocular infection;
- history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
- moderate to severe asthma;
- dry eye syndrome;
- history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
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 |
|---|---|---|
| R89674 0.025% ophthalmic solution | Drug | – |
Primary outcome
Ocular itching and redness scores at defined timepoints
1 secondary outcome
QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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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.
Reza Haque, MD study director
Vistakon Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing R89674 0.025% ophthalmic solution in people with Allergic Conjunctivitis, run by Vistakon Pharmaceuticals at 6 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ocular itching and redness scores at defined timepoints. 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 27 Sep 2011.