Open-Angle GlaucomaPhase 3NCT00047528
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-02-41
A Phase 3 study testing Alcon Investigational Agent in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Alcon Investigational Agent
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Nov 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Safety and Efficacy Study to Evaluate Combination IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertensive Patients (C-02-41).
To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- Alcon Investigational Agent
- Keywords
- open-angle, glaucoma, ocular, hypertension, POAG
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon Investigational AgentDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2002 (estimated)
- Study startJan 2001
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-Angle GlaucomaStudies 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
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047528
- Sponsor's protocol ID
- C-02-41
- Other IDs
- C-02-41
- Status last verified
- Aug 2008
- First submitted
- 8 Oct 2002
- Last updated
- 5 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Safety and Efficacy Study to Evaluate Combination IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertensive Patients (C-02-41).
- ClinicalTrials.gov ID
- NCT00047528
- Acronym / sponsor ID
- C-02-41
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- open-angle, glaucoma, ocular, hypertension, POAG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 18 Oct 2002 (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.
To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Alcon Investigational Agent | Drug | – |
Primary outcome
Not reported in the source record.
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 5 Aug 2008.
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Impact of Glaucoma and Visual Field Loss on Life Space
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alcon Investigational Agent in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site 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?
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 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 5 Aug 2008.