Open-angle GlaucomaPhase 2NCT00069706
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
A Phase 2 study testing AL-12182 0.003% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution and AL-12182 0.01% Ophthalmic Solution in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy 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-12182 0.003% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution and AL-12182 0.01% Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Oct 2003
- 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
- 18 years or older.
- Diagnosis of open-angle glaucoma or ocular hypertension.
- LogMAR visual acuity not worse than 0.6.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Clinically relevant ophthalmic or systemic conditions.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- AL-12182 0.003% Ophthalmic Solution, AL-12182 Ophthalmic Solution Vehicle, Latanoprost 0.005% Ophthalmic Solution, AL-12182 0.01% Ophthalmic Solution, AL-12182 0.03% Ophthalmic Solution
- 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.
AL-12182 0.003% Ophthalmic SolutionDrug
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
AL-12182 Ophthalmic Solution VehicleOther
Placebo
Latanoprost 0.005% Ophthalmic SolutionDrug
Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
AL-12182 0.01% Ophthalmic SolutionDrug
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
AL-12182 0.03% Ophthalmic SolutionDrug
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
| Study group | Role | What they receive |
|---|---|---|
| AL-12182 0.003% | Experimental | One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days Receives: Drug: AL-12182 0.003% Ophthalmic Solution |
| AL-12182 Solution Vehicle | Placebo comparator | One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days Receives: Other: AL-12182 Ophthalmic Solution Vehicle |
| Latanoprost | Active comparator | One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days Receives: Drug: Latanoprost 0.005% Ophthalmic Solution |
| AL-12182 0.01% | Experimental | One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days Receives: Drug: AL-12182 0.01% Ophthalmic Solution |
| AL-12182 0.03% | Experimental | One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days Receives: Drug: AL-12182 0.03% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2003 (estimated)
- Study startJul 2003
- Primary completionOct 2003
- Study completionOct 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 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
- NCT00069706
- Sponsor's protocol ID
- C-03-25
- Status last verified
- Feb 2012
- First submitted
- 30 Sep 2003
- Last updated
- 14 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
- ClinicalTrials.gov ID
- NCT00069706
- Acronym / sponsor ID
- C-03-25
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- open-angle, glaucoma, ocular, hypertension, POAG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 6 Oct 2003 (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 the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AL-12182 0.003% | Experimental | Drug: AL-12182 0.003% Ophthalmic SolutionOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days |
| AL-12182 Solution Vehicle | Placebo comparator | Other: AL-12182 Ophthalmic Solution VehicleOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days |
| Latanoprost | Active comparator | Drug: Latanoprost 0.005% Ophthalmic SolutionOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days |
| AL-12182 0.01% | Experimental | Drug: AL-12182 0.01% Ophthalmic SolutionOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days |
| AL-12182 0.03% | Experimental | Drug: AL-12182 0.03% Ophthalmic SolutionOne drop in the study eye(s) once daily at approximately 8 a.m. for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older.
- Diagnosis of open-angle glaucoma or ocular hypertension.
- LogMAR visual acuity not worse than 0.6.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Clinically relevant ophthalmic or systemic conditions.
- 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-12182 0.003% Ophthalmic SolutionInvestigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension | Drug | AL-12182 0.003% |
| AL-12182 Ophthalmic Solution VehiclePlacebo | Other | AL-12182 Solution Vehicle |
| Latanoprost 0.005% Ophthalmic SolutionCommercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension | Drug | Latanoprost |
| AL-12182 0.01% Ophthalmic SolutionInvestigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension | Drug | AL-12182 0.01% |
| AL-12182 0.03% Ophthalmic SolutionInvestigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension | Drug | AL-12182 0.03% |
Primary outcome
Mean Intraocular Pressure (IOP)
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 14 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-12182 0.003% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution and AL-12182 0.01% Ophthalmic Solution in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research.
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 4 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 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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 Intraocular Pressure (IOP). 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 14 Feb 2012.