Open-Angle GlaucomaPhase 2NCT00620256
Adjunctive Study of AL-37807 Ophthalmic Suspension
A Phase 2 study testing AL-37807 ophthalmic suspension, 0.1%, Timolol gel forming solution, 0.5% and Latanoprost ophthalmic solution in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in 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, 0.1%, Timolol gel forming solution, 0.5% and Latanoprost ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jul 2008
- 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
- Open-angle glaucoma
- Ocular hypertension
- Must have been on Xalatan for at least 3 months
- VA not worse than 0.60
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Age related
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center at 1-888-451-3937
Fort Worth, Texas, 76134
About this study
Official title: Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension
The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- AL-37807 ophthalmic suspension, 0.1%, Timolol gel forming solution, 0.5%, AL-37807 ophthalmic solution vehicle, Latanoprost ophthalmic solution
- Keywords
- Glaucoma, 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, 0.1%Drug
Timolol gel forming solution, 0.5%Drug
AL-37807 ophthalmic solution vehicleOther
Latanoprost ophthalmic solutionDrug
Also called XALATAN
| Study group | Role | What they receive |
|---|---|---|
| AL-37807 | Experimental | AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks Receives: Drug: AL-37807 ophthalmic suspension, 0.1%; Drug: Latanoprost ophthalmic solution |
| Timolol | Active comparator | Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks Receives: Drug: Timolol gel forming solution, 0.5%; Drug: Latanoprost ophthalmic solution |
| AL-37807 vehicle | Placebo comparator | AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks Receives: Drug: AL-37807 ophthalmic suspension, 0.1%; Other: AL-37807 ophthalmic solution vehicle; Drug: Latanoprost ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in intraocular pressure
Measured: Baseline, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionJul 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 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
- NCT00620256
- Sponsor's protocol ID
- C-07-05
- Status last verified
- Dec 2012
- First submitted
- 11 Feb 2008
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00620256
- Acronym / sponsor ID
- C-07-05
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 21 Feb 2008 (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 the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL-37807 | Experimental | Drug: AL-37807 ophthalmic suspension, 0.1%, Drug: Latanoprost ophthalmic solutionAL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks |
| Timolol | Active comparator | Drug: Timolol gel forming solution, 0.5%, Drug: Latanoprost ophthalmic solutionTimolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks |
| AL-37807 vehicle | Placebo comparator | Drug: AL-37807 ophthalmic suspension, 0.1%, Other: AL-37807 ophthalmic solution vehicle, Drug: Latanoprost ophthalmic solutionAL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Open-angle glaucoma
- Ocular hypertension
- Must have been on Xalatan for at least 3 months
- VA not worse than 0.60
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (2 listed)
- Age related
- 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, 0.1% | Drug | AL-37807, AL-37807 vehicle |
| Timolol gel forming solution, 0.5% | Drug | Timolol |
| AL-37807 ophthalmic solution vehicle | Other | AL-37807 vehicle |
| Latanoprost ophthalmic solutionAlso: XALATAN | Drug | AL-37807, AL-37807 vehicle, Timolol |
Primary outcome
Mean change from baseline in intraocular pressure
Time frame: Baseline, up to 4 weeks
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 Dec 2012.
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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 2 study testing AL-37807 ophthalmic suspension, 0.1%, Timolol gel forming solution, 0.5% and Latanoprost ophthalmic solution 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 5 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 Dec 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 change from baseline in intraocular pressure (time frame: Baseline, up to 4 weeks). 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 Dec 2012.