GlaucomaPhase 3NCT00576342
Patient Preference Study
A Phase 3 study testing AL-3862+timolol ophthalmic suspension and Dorzolamide+timolol ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- AL-3862+timolol ophthalmic suspension and Dorzolamide+timolol ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Jan 2008
- Phase
- Phase 3
- 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
- Sign informed consent;
- Diagnosis of glaucoma or ocular hypertension;
- On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy);
- IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health;
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye;
- Pregnant, nursing, or not using highly effective birth control methods;
- Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study;
- History of bronchial asthma or severe chronic obstructive pulmonary disease;
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension
In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- AL-3862+timolol ophthalmic suspension, Dorzolamide+timolol ophthalmic solution
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-3862+timolol ophthalmic suspensionDrug
Dorzolamide+timolol ophthalmic solutionDrug
Also called COSOPT
| Study group | Role | What they receive |
|---|---|---|
| AL-3862+timolol, then COSOPT | Other | AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later. Receives: Drug: AL-3862+timolol ophthalmic suspension; Drug: Dorzolamide+timolol ophthalmic solution |
| COSOPT, then AL-3862+timolol | Other | Dorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later. Receives: Drug: AL-3862+timolol ophthalmic suspension; Drug: Dorzolamide+timolol ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with a stated preference for either study medication
Measured: Day 2
Secondary outcomes (1)
Mean ocular discomfort score
Measured: Day 1, 1 minute after drop instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT00576342
- Sponsor's protocol ID
- C-07-47
- Status last verified
- Jul 2014
- First submitted
- 17 Dec 2007
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Patient Preference Study Comparison in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00576342
- Acronym / sponsor ID
- C-07-47
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Dec 2007 (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.
In this randomized crossover study, patients will receive a single drop of two test articles and assess comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-3862+timolol, then COSOPT | Other | Drug: AL-3862+timolol ophthalmic suspension, Drug: Dorzolamide+timolol ophthalmic solutionAL-3862+timolol ophthalmic suspension, 1 drop in both eyes, followed by dorzolamide+timolol ophthalmic solution,1 drop in both eyes, 1 day later. |
| COSOPT, then AL-3862+timolol | Other | Drug: AL-3862+timolol ophthalmic suspension, Drug: Dorzolamide+timolol ophthalmic solutionDorzolamide+timolol ophthalmic solution, 1 drop in both eyes, followed by AL-3862+timolol ophthalmic suspension, 1 drop in both eyes, 1 day later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign informed consent;
- Diagnosis of glaucoma or ocular hypertension;
- On a stable regimen of any intraocular pressure (IOP) lowering medication (mono-therapy);
- IOP for which, in the opinion of the investigator, participation in the study does not present a risk to ocular health;
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Best corrected visual acuity worse than 0.60 logMAR (20/80 Snellen) in either eye;
- Pregnant, nursing, or not using highly effective birth control methods;
- Use of oral or topical corticosteroids within 30 days of the Screening Visit and during the course of the study;
- History of bronchial asthma or severe chronic obstructive pulmonary disease;
- 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-3862+timolol ophthalmic suspension | Drug | AL-3862+timolol, then COSOPT, COSOPT, then AL-3862+timolol |
| Dorzolamide+timolol ophthalmic solutionAlso: COSOPT | Drug | AL-3862+timolol, then COSOPT, COSOPT, then AL-3862+timolol |
Primary outcome
Percentage of patients with a stated preference for either study medication
Time frame: Day 2
1 secondary outcome
Mean ocular discomfort score
Time frame: Day 1, 1 minute after drop instillation
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 11 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.
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 3 study testing AL-3862+timolol ophthalmic suspension and Dorzolamide+timolol ophthalmic solution in people with 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 5 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 11 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of patients with a stated preference for either study medication (time frame: Day 2). 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 11 Jul 2014.