Open-angle GlaucomaPhase 2NCT00287521
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
A Phase 2 study testing AL-37807 Ophthalmic Suspension, 1.0%, Latanoprost, 0.005% (Xalatan) and Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension. 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?
- AL-37807 Ophthalmic Suspension, 1.0%, Latanoprost, 0.005% (Xalatan) and Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Feb 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Under 18
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
United States Investigative Sites in Texas and Other States
Fort Worth, Texas, 76180
About this study
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- AL-37807 Ophthalmic Suspension, 1.0%, Latanoprost, 0.005% (Xalatan), AL-37807 Vehicle, Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%
- Keywords
- open, angle, glaucoma, ocular, hypertension
- 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.
AL-37807 Ophthalmic Suspension, 1.0%Drug
One drop in the study eye(s) once daily for 28 days
Latanoprost, 0.005% (Xalatan)Drug
Also called XALATAN
One drop in the study eye(s) once daily for 28 days
AL-37807 VehicleOther
One drop in the study eye(s) once daily for 28 days
Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%Drug
One drop in the study eye(s) once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| AL-37807 Suspension | Experimental | Not described Receives: Drug: AL-37807 Ophthalmic Suspension, 1.0% |
| Xalatan | Active comparator | Not described Receives: Drug: Latanoprost, 0.005% (Xalatan) |
| AL-37807 Vehicle | Placebo comparator | Not described Receives: Other: AL-37807 Vehicle |
| Timolol Maleate | Experimental | Not described Receives: Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionFeb 2006
- Study completionFeb 2006
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.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287521
- Sponsor's protocol ID
- C-04-68
- Status last verified
- Mar 2012
- First submitted
- 3 Feb 2006
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00287521
- Acronym / sponsor ID
- C-04-68
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- open, angle, glaucoma, ocular, hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 7 Feb 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 study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AL-37807 Suspension | Experimental | Drug: AL-37807 Ophthalmic Suspension, 1.0% |
| Xalatan | Active comparator | Drug: Latanoprost, 0.005% (Xalatan) |
| AL-37807 Vehicle | Placebo comparator | Other: AL-37807 Vehicle |
| Timolol Maleate | Experimental | Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Under 18
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| AL-37807 Ophthalmic Suspension, 1.0%One drop in the study eye(s) once daily for 28 days | Drug | AL-37807 Suspension |
| Latanoprost, 0.005% (Xalatan)Also: XALATANOne drop in the study eye(s) once daily for 28 days | Drug | Xalatan |
| AL-37807 VehicleOne drop in the study eye(s) once daily for 28 days | Other | AL-37807 Vehicle |
| Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%One drop in the study eye(s) once daily for 28 days | Drug | Timolol Maleate |
Primary outcome
Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0)
Time frame: Day 28
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 Mar 2012.
Related trials for Open-angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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 2 study testing AL-37807 Ophthalmic Suspension, 1.0%, Latanoprost, 0.005% (Xalatan) and Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% 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?
The sponsor lists 2 inclusion and 2 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 5 Mar 2012. 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. 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 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?
Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0) (time frame: Day 28). 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 5 Mar 2012.