Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic ConjunctivitisPhase 3NCT00223951
Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers
A Phase 3 study testing R89674 (generic name not yet established) in people with Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis, run by Vistakon Pharmaceuticals at 6 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis
- What is being tested?
- R89674 (generic name not yet established)
- How many people
- 900 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy normal volunteers age >=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better
- -
Who cannot join
- intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female < 18 years of age -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Bel Air, Maryland, 21014
Study site
Charlotte, North Carolina, 28204
Study site
Las Vegas, Nevada, 89102
Study site
North Andover, Massachusetts, 01845
Study site
Philadelphia, Pennsylvania, 19148
Study site
Phoenix, Arizona, 85032
About this study
Official title: A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers
The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers
- Being tested
- R89674 (generic name not yet established)
- Keywords
- Healthy volunteers, safety, 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.
Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination
Secondary outcomes (1)
No additional endpoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 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 Healthy Volunteers Eligible for Study; Drug Being Developed 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
- 900 participants
Sponsor and investigators
- Lead sponsor
- Vistakon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack V Greiner, OD, DO, PhD, Principal investigator, Ophthalmic Research Associates, North Andover, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223951
- Sponsor's protocol ID
- 05-003-10
- Status last verified
- Feb 2015
- First submitted
- 20 Sep 2005
- Last updated
- 20 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers
- ClinicalTrials.gov ID
- NCT00223951
- Acronym / sponsor ID
- 05-003-10
- Keywords
- Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (actual)
- First posted
- 22 Sep 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 evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- healthy normal volunteers age >=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better
- -
Key exclusion criteria (1 listed)
- intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female < 18 years of age -
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
Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination
1 secondary outcome
No additional endpoints
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 20 Feb 2015.
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.
Jack V Greiner, OD, DO, PhD principal investigator
Ophthalmic Research Associates, North Andover, MA
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 (generic name not yet established) in people with Healthy Volunteers Eligible for Study; Drug Being Developed for 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 1 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 20 Feb 2015. 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?
Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination. 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 20 Feb 2015.