Open-Angle GlaucomaPhase 4NCT01327599
Efficacy of Changing to DUOTRAV® From Prior Therapy
A Phase 4 study testing Travoprost 0.004%+Timolol 0.5% ophthalmic 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 efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma
- What is being tested?
- Travoprost 0.004%+Timolol 0.5% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
- Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit.
- IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.
- IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye).
- Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
- Able to follow instructions and willing and able to attend all study visits.
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- Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
- Sign informed consent.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
- Corneal dystrophies in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- History of severe allergic rhinitis.
- A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
- Participation in any other investigational study within 30 days prior to the Screening Visit.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Assessing the Efficacy and Tolerability of Changing to DUOTRAV® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)
The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).
- Being tested
- Travoprost 0.004%+Timolol 0.5% ophthalmic solution
- Keywords
- Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma, Intraocular pressure
- 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.
Travoprost 0.004%+Timolol 0.5% ophthalmic solutionDrug
Also called DUOTRAV®
Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)
| Study group | Role | What they receive |
|---|---|---|
| DUOTRAV® | Experimental | Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks Receives: Drug: Travoprost 0.004%+Timolol 0.5% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline
IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.
Measured: Week 12
Secondary outcomes (4)
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline
The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health.
Measured: Week 12
Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline
Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis.
Measured: Week 12
Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline
IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.
Measured: Week 4, Week 12
Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline
IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Severine Durier, Pharm.D, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327599
- Sponsor's protocol ID
- RDG-10-272
- Other IDs
- 2011-000161-13
- Status last verified
- Jan 2014
- First submitted
- 30 Mar 2011
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Tolerability of Changing to DUOTRAV® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)
- ClinicalTrials.gov ID
- NCT01327599
- Acronym / sponsor ID
- RDG-10-272
- Keywords
- Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma, Intraocular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Posted 10 Jan 2014
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 efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DUOTRAV® | Experimental | Drug: Travoprost 0.004%+Timolol 0.5% ophthalmic solutionTravoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
- Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit.
- IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.
- IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye).
- Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
Key exclusion criteria (8 listed)
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
- Corneal dystrophies in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- History of severe allergic rhinitis.
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 |
|---|---|---|
| Travoprost 0.004%+Timolol 0.5% ophthalmic solutionAlso: DUOTRAV®Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD) | Drug | DUOTRAV® |
Primary outcome
Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline
Time frame: Week 12
IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.
4 secondary outcomes
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline
Time frame: Week 12
Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline
Time frame: Week 12
Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline
Time frame: Week 4, Week 12
Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Severine Durier, Pharm.D study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travoprost 0.004%+Timolol 0.5% 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 9 inclusion and 8 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 10 Feb 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 IOP at Week 12 in Subjects Using Ganfort® at Baseline (time frame: Week 12). 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 10 Feb 2014.