Open-angle Glaucoma (OAG)Phase 2NCT01318252
AL-54478 Proof of Concept Study
A Phase 2 study testing AL-54478 0.005% and Latanoprost 0.005% in people with Open-angle Glaucoma (OAG) and Ocular Hypertension (OHT), run by Alcon Research.
Trial summary
The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle 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 (OAG), Ocular Hypertension (OHT)
- What is being tested?
- AL-54478 0.005% and Latanoprost 0.005%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Oct 2011
- 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
- Patients diagnosed with either OAG or OHT.
- Patients who are able to comply with the scheduled visits.
- Patients who have had a physical exam within 6 months of the Screening Visit.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Females of childbearing potential who meet any 1 of the following conditions: a) Currently pregnant; b) Positive urine pregnancy test; c)Intend to become pregnant; d) Breast feeding; e) Not using highly effective birth control measures.
- Patients with extreme narrow angle with complete or partial closure.
- Patients with a cup to disc ratio more than 0.8.
- Patients with a severe central visual field loss in either eye.
- Patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation.
- Patients who have had ocular trauma within the past 6 months or have had intraocular surgery within the past 6 months or have had ocular laser surgery within the past 3 months.
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- Patients with best-correct visual acuity less than 20/80.
- Patients who have had ocular infection or inflammation within the past 3 months.
- Patients who have clinically relevant progressive retinal disease.
- Patients who have severe illness or conditions.
- Patients who have hypersensitivity to a prostaglandin analogu.e
- Patients who are unable to safely discontinue all IOP-lowering medications during washout.
- Patients who are currently on therapy with another investigational agent within 30 days prior to the Screening Visit.
- Other protocol-defined exclusion criteria may apply.
About this study
The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular hypertension.
- Being tested
- AL-54478 0.005%, Latanoprost 0.005%, AL-54478 Vehicle
- Keywords
- Elevated IOP
- 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-54478 0.005%Drug
Latanoprost 0.005%Drug
AL-54478 VehicleDrug
Inactive ingredients used as a placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| AL-54478 | Experimental | AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing Receives: Drug: AL-54478 0.005% |
| Latanoprost | Active comparator | Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing Receives: Drug: Latanoprost 0.005% |
| Vehicle | Placebo comparator | AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing Receives: Drug: AL-54478 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle Glaucoma (OAG)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravaughn Williams, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318252
- Sponsor's protocol ID
- C-10-080
- Status last verified
- Jul 2014
- First submitted
- 16 Mar 2011
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AL-54478 Proof of Concept Study
- ClinicalTrials.gov ID
- NCT01318252
- Acronym / sponsor ID
- C-10-080
- Keywords
- Elevated IOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 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 is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL-54478 | Experimental | Drug: AL-54478 0.005%AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing |
| Latanoprost | Active comparator | Drug: Latanoprost 0.005%Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing |
| Vehicle | Placebo comparator | Drug: AL-54478 VehicleAL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with either OAG or OHT.
- Patients who are able to comply with the scheduled visits.
- Patients who have had a physical exam within 6 months of the Screening Visit.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (14 listed)
- Females of childbearing potential who meet any 1 of the following conditions: a) Currently pregnant; b) Positive urine pregnancy test; c)Intend to become pregnant; d) Breast feeding; e) Not using highly effective birth control measures.
- Patients with extreme narrow angle with complete or partial closure.
- Patients with a cup to disc ratio more than 0.8.
- Patients with a severe central visual field loss in either eye.
- Patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation.
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-54478 0.005% | Drug | AL-54478 |
| Latanoprost 0.005% | Drug | Latanoprost |
| AL-54478 VehicleInactive ingredients used as a placebo comparator | Drug | Vehicle |
Primary outcome
24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing
Time frame: Day 14
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 31 Jul 2014.
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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.
Ravaughn Williams study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-54478 0.005% and Latanoprost 0.005% in people with Open-angle Glaucoma (OAG) and Ocular Hypertension (OHT), 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 14 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 31 Jul 2014. 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?
24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing (time frame: Day 14). 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 31 Jul 2014.