Ocular HypertensionPhase 3NCT01168414
A Study of Ganfort Versus Duotrav in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Ganfort and Duotrav in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by Ministry of Health, Malaysia at 1 site in Malaysia.
Trial summary
This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Hypertension, Primary Open Angle Glaucoma
- What is being tested?
- Ganfort and Duotrav
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2010to Feb 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Visual acuity 6/60 or better
- Patients who are controlled (IOP < 21 mmHg) on non-fixed combination of Latanoprost \& Timolol for at least 3 months before the baseline visit and
- Patients on mono-therapy either Latanoprost or Timolol who are eligible for dual therapy being not satisfactorily controlled (IOP>21mmHG)
Who cannot join
- Angle closure glaucoma
- Neovascular Galucoma
- Secondary open angle glaucoma
- Ocular infection/inflammation within 3 months
- Ocular surgery within 3 months
- History of Refractive surgery
Show all 11Show fewer
- Argon laser trabeculoplasty/Selective laser trabeculoplasty
- Pregnancy/nursing
- Hypersensitivity to benzalkonium chloride or to any other components of the trial drugs solution.
- Patients in whom beta-blockers are contraindicated
- Patients on any drugs known to affect IOP.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Ophthalmology Department, Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
About this study
Official title: A Randomized, Comparison of the Effects of Ganfort and Duotrav on Intraocular Pressure in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Open Label/Evaluator-blind/Cross-over Study
This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each.
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Being tested
- Ganfort, Duotrav
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanfortDrug
Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)
DuotravDrug
Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)
| Study group | Role | What they receive |
|---|---|---|
| Ganfort | Active comparator | Fixed combination of Bimatoprost and Timolol Receives: Drug: Ganfort |
| Duotrav | Active comparator | Fixed combination of Travoprost and Timolol Receives: Drug: Duotrav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intraocular pressure of the 12-hour IOP curve
To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav
Measured: 8 weeks
Secondary outcomes (1)
Mean intraocular pressure
Difference in mean IOP for Ganfort and Duotrav
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168414
- Sponsor's protocol ID
- NMRR-10-466-5929
- Status last verified
- Jul 2010
- First submitted
- 21 Jul 2010
- Last updated
- 8 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparison of the Effects of Ganfort and Duotrav on Intraocular Pressure in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Open Label/Evaluator-blind/Cross-over Study
- ClinicalTrials.gov ID
- NCT01168414
- Acronym / sponsor ID
- NMRR-10-466-5929
- Conditions
- Ocular Hypertension, Primary Open Angle Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Jul 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.
This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganfort | Active comparator | Drug: GanfortFixed combination of Bimatoprost and Timolol |
| Duotrav | Active comparator | Drug: DuotravFixed combination of Travoprost and Timolol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Visual acuity 6/60 or better
- Patients who are controlled (IOP < 21 mmHg) on non-fixed combination of Latanoprost \& Timolol for at least 3 months before the baseline visit and
- Patients on mono-therapy either Latanoprost or Timolol who are eligible for dual therapy being not satisfactorily controlled (IOP>21mmHG)
Key exclusion criteria (11 listed)
- Angle closure glaucoma
- Neovascular Galucoma
- Secondary open angle glaucoma
- Ocular infection/inflammation within 3 months
- Ocular surgery within 3 months
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 |
|---|---|---|
| GanfortFixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution) | Drug | Ganfort |
| DuotravFixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution) | Drug | Duotrav |
Primary outcome
Mean intraocular pressure of the 12-hour IOP curve
Time frame: 8 weeks
To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav
1 secondary outcome
Mean intraocular pressure
Time frame: 12 hours
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 8 Jul 2011.
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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 3 study testing Ganfort and Duotrav in people with Ocular Hypertension and Primary Open Angle Glaucoma, run by Ministry of Health, Malaysia at 1 site in Malaysia.
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 3 inclusion and 11 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 8 Jul 2011. 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 Malaysia. 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 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?
Mean intraocular pressure of the 12-hour IOP curve (time frame: 8 weeks). 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 8 Jul 2011.