Allergic ConjunctivitisPhase 3NCT00241319
Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis
A Phase 3 study testing R89674 (generic name not yet established) in people with Allergic Conjunctivitis, run by Vistakon Pharmaceuticals at 5 sites in United States.
Trial summary
The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced 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 (generic name not yet established)
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2005to Dec 2005
- 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 ocular allergies and a positive skin test reaction to cat hair,
- cat dander, grasses, ragweed, and/or trees within the past 24 months;
- calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction
Who cannot join
- narrow angle glaucoma,
- clinically significant blepharitis, follicular conjunctivitis, iritis
- pterygium or diagnosis of dry eye
- ocular surgical intervention within 3 months
- history of refractive surgery within 6 months
- known history of retinal detachment, diabetic retinopathy, or progressive retinal disease
- presence of active ocular infection positive history of an ocular herpetic infection
- preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Charlotte, North Carolina
Study site
Indianapolis, Indiana
Study site
Lewiston, Maine
Study site
Philadelphia, Pennsylvania
Study site
Rochester, New York
About this study
Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis
- Conditions
- Allergic Conjunctivitis
- Being tested
- R89674 (generic name not yet established)
- Keywords
- ocular, allergic conjunctivitis, ophthalmic
- 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 (generic name not yet established)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itching and conjunctival redness post challenge
Secondary outcomes (1)
Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2005
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
- 150 participants
Sponsor and investigators
- Lead sponsor
- Vistakon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingerman Avner, MD, Study director, Johnson & Johnson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241319
- Sponsor's protocol ID
- 05-003-11
- Status last verified
- Sep 2011
- First submitted
- 14 Oct 2005
- 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, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT00241319
- Acronym / sponsor ID
- 05-003-11
- Conditions
- Allergic Conjunctivitis
- Keywords
- ocular, allergic conjunctivitis, ophthalmic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2005 (actual)
- First posted
- 18 Oct 2005 (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 study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced 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 (3 listed)
- history of ocular allergies and a positive skin test reaction to cat hair,
- cat dander, grasses, ragweed, and/or trees within the past 24 months;
- calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction
Key exclusion criteria (8 listed)
- narrow angle glaucoma,
- clinically significant blepharitis, follicular conjunctivitis, iritis
- pterygium or diagnosis of dry eye
- ocular surgical intervention within 3 months
- history of refractive surgery within 6 months
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 (generic name not yet established) | Drug | – |
Primary outcome
Ocular itching and conjunctival redness post challenge
1 secondary outcome
Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
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.
Ingerman Avner, MD study director
Johnson & Johnson
5 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 (generic name not yet established) in people with Allergic Conjunctivitis, run by Vistakon Pharmaceuticals at 5 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 3 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: 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 5 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 conjunctival redness post challenge. 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.