Open-angle GlaucomaPhase 2NCT01312454
Safety and Intraocular Pressure (IOP) Lowering Effect of AL-59412C
A Phase 2 study testing AL-59412C injectable solution and Travoprost injectable solution in people with Open-angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle. 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-59412C injectable solution and Travoprost injectable solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jan 2012
- 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
- Diagnosis of primary open-angle glaucoma or ocular hypertension.
- Retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye.
- Able to discontinue all intraocular-lowering (IOP) medications according to the minimum washout period, based upon the class of medication.
- Mean washed out IOP ≥ 24 millimeters mercury (mmHg) to ≤ 36 mmHg at 8 AM in the study eye on two separate Eligibility Visits.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye.
- Current or recent (within 30 days) use of any drug that may prolong the QT interval.
- Poor vision resulting from advanced glaucoma in the study eye.
- Intraocular surgery within the past 6 months in the study eye.
- Ocular laser surgery within the past 3 months in the study eye.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Proof of Concept Study to Assess the Safety and IOP-Lowering Effect of AL-59412C Injected Intravitreally
The purpose of this study was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- AL-59412C injectable solution, Travoprost injectable solution, AL-59412C Vehicle
- Keywords
- intravitreal injection, intraocular pressure, open-angle glaucoma, ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-59412C injectable solutionDrug
Concentration 1 and Concentration 2
Travoprost injectable solutionDrug
AL-59412C VehicleDrug
Inactive ingredients used as placebo
| Study group | Role | What they receive |
|---|---|---|
| AL-59412C Concentration 1 | Experimental | AL-59412C injectable solution, single intravitreal injection Receives: Drug: AL-59412C injectable solution |
| AL-59412C Concentration 2 | Experimental | AL-59412C injectable solution, single intravitreal injection Receives: Drug: AL-59412C injectable solution |
| Travoprost | Active comparator | Travoprost injectable solution, single intravitreal injection Receives: Drug: Travoprost injectable solution |
| Vehicle | Placebo comparator | AL-59412C Vehicle, single intravitreal injection Receives: Drug: AL-59412C Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection
IOP was measured by Goldman applanation tonometry at protocol-specified timepoints, up to 24 hours post-injection.
Measured: Time to event, up to 24 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Management decision
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Landry, PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312454
- Sponsor's protocol ID
- C-10-038
- Status last verified
- Sep 2013
- First submitted
- 4 Mar 2011
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Assess the Safety and IOP-Lowering Effect of AL-59412C Injected Intravitreally
- ClinicalTrials.gov ID
- NCT01312454
- Acronym / sponsor ID
- C-10-038
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Keywords
- intravitreal injection, intraocular pressure, open-angle glaucoma, ocular hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Management decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Mar 2011 (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 was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AL-59412C Concentration 1 | Experimental | Drug: AL-59412C injectable solutionAL-59412C injectable solution, single intravitreal injection |
| AL-59412C Concentration 2 | Experimental | Drug: AL-59412C injectable solutionAL-59412C injectable solution, single intravitreal injection |
| Travoprost | Active comparator | Drug: Travoprost injectable solutionTravoprost injectable solution, single intravitreal injection |
| Vehicle | Placebo comparator | Drug: AL-59412C VehicleAL-59412C Vehicle, single intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of primary open-angle glaucoma or ocular hypertension.
- Retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye.
- Able to discontinue all intraocular-lowering (IOP) medications according to the minimum washout period, based upon the class of medication.
- Mean washed out IOP ≥ 24 millimeters mercury (mmHg) to ≤ 36 mmHg at 8 AM in the study eye on two separate Eligibility Visits.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 listed)
- Lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye.
- Current or recent (within 30 days) use of any drug that may prolong the QT interval.
- Poor vision resulting from advanced glaucoma in the study eye.
- Intraocular surgery within the past 6 months in the study eye.
- Ocular laser surgery within the past 3 months in the study eye.
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-59412C injectable solutionConcentration 1 and Concentration 2 | Drug | AL-59412C Concentration 1, AL-59412C Concentration 2 |
| Travoprost injectable solution | Drug | Travoprost |
| AL-59412C VehicleInactive ingredients used as placebo | Drug | Vehicle |
Primary outcome
Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection
Time frame: Time to event, up to 24 hours post-injection
IOP was measured by Goldman applanation tonometry at protocol-specified timepoints, up to 24 hours post-injection.
Results and safety
The study was stopped early (reason given: Management decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
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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.
Theresa Landry, PhD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-59412C injectable solution and Travoprost injectable 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 25 Oct 2013. 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 was stopped early (reason given: Management decision). Results are not available in the source record.
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?
Maximum intraocular (IOP) reduction from baseline up to 24 hours post-injection (time frame: Time to event, up to 24 hours post-injection). 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 25 Oct 2013.