GlaucomaPhase 4NCT01230736
Safety and Efficacy of Changing to DuoTrav From Prior Therapy
A Phase 4 study testing Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®) in people with Glaucoma, run by Alcon Research at 1 site in Germany.
Trial summary
The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled 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
- Glaucoma
- What is being tested?
- Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Feb 2011
- Phase
- Phase 4
- 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
- Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
- Must be 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.
- Women who are pregnant or lactating.
- 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.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Safety and Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients Uncontrolled on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)
The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Glaucoma
- Being tested
- Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)
- Medical subject headings
- Glaucoma
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% Fixed Combination eye drops solution (Duotrav®)Drug
Also called DuoTrav®
One drop in study eye(s) once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| DuoTrav | Experimental | One drop in study eye(s) once daily for 8 weeks Receives: Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline)
Goldmann applanation tonometry will be performed at the baseline visit and 8-week visit to record intraocular pressure (IOP). The difference between the two readings will be recorded as the change in IOP. IOP will be recorded in mmHg.
Measured: 8 weeks
Secondary outcomes (1)
Percentage of subjects who reach target IOP (≤18 mmHg)
Goldmann applanation tonometry will be performed at the 8-week visit to record intraocular pressure. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18 mmHg to the overall study population.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 105 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
- NCT01230736
- Sponsor's protocol ID
- RDG-10-243
- Status last verified
- Apr 2012
- First submitted
- 28 Oct 2010
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Scherzer ML, Liehneova I, Negrete FJ, Schnober D. Travoprost 0.004%/timolol 0.5% fixed combination in patients transitioning from fixed or unfixed bimatoprost 0.03%/timolol 0.5%. Adv Ther. 2011 Aug;28(8):661-70. doi: 10.1007/s12325-011-0043-z. Epub 2011 Jul 15.
PubMed 21773673
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety and Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients Uncontrolled on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)
- ClinicalTrials.gov ID
- NCT01230736
- Acronym / sponsor ID
- RDG-10-243
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Oct 2010 (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 to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.
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% Fixed Combination eye drops solution (Duotrav®)One drop in study eye(s) once daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
- Must be 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.
- Women who are pregnant or lactating.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (6 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% Fixed Combination eye drops solution (Duotrav®)Also: DuoTrav®One drop in study eye(s) once daily for 8 weeks | Drug | DuoTrav |
Primary outcome
Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline)
Time frame: 8 weeks
Goldmann applanation tonometry will be performed at the baseline visit and 8-week visit to record intraocular pressure (IOP). The difference between the two readings will be recorded as the change in IOP. IOP will be recorded in mmHg.
1 secondary outcome
Percentage of subjects who reach target IOP (≤18 mmHg)
Time frame: 8 weeks
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 21 Nov 2016.
- Results publication: PubMed 21773673Scherzer ML, Liehneova I, Negrete FJ, Schnober D. Travoprost 0.004%/timolol 0.5% fixed combination in patients transitioning from fixed or unfixed bimatoprost 0.03%/timolol 0.5%. Adv Ther. 2011 Aug;28(8):661-70. doi: 10.1007/s12325-011-0043-z. Epub 2011 Jul 15.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®) in people with Glaucoma, run by Alcon Research at 1 site in Germany.
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: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230736, which also lists 1 linked publication.
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 21 Nov 2016.