GlaucomaNCT01542710
Bimatoprost/Timolol Versus Travoprost/Timolol
A study testing Ganfort and Duotrav in people with Glaucoma, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The purpose of this study is to compare 2 fixed combination medications in intraocular pressure lowering. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- What is being tested?
- Ganfort and Duotrav
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2011to Dec 2011
- Phase
- Interventional
- 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
- Glaucoma
Who cannot join
- No other ocular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bimatoprost/Timolol Versus Travoprost/Timolol Fixed Combinations in an Egyptian Population: A Hospital-Based Prospective Randomized Study
The purpose of this study is to compare 2 fixed combination medications in intraocular pressure lowering.
Read the detailed description
PURPOSE: To compare the efficacy of bimatoprost/timolol (BTFC) or travoprost/timolol (TTFC) fixed combinations on intraocular pressure (IOP) reduction in an Egyptian population.
METHODS: Patients with primary open angle glaucoma (POAG) were randomized to receive either BTFC or TTFC. IOPs were measured at baseline, 2 weeks, and 1, 2, 4, and 6 months. The primary outcome measures were the mean change in IOP from baseline
- Conditions
- Glaucoma
- Being tested
- Ganfort, Duotrav
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanfortDrug
Also called Bimatoprost/Timolol vs Travoprost/Timolol fixed combination
Bimatoprost/Timolol fixed combination
DuotravDrug
Fixed combination of Travoprost and Timolol
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma fixed Combination Medications | Experimental | Not described Receives: Drug: Ganfort; Drug: Duotrav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of drop of intraocular pressures from baseline.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer A Macky, Kasr El Aini Hospital
- Investigators
- Tamer A Macky, MD FRCS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542710
- Sponsor's protocol ID
- Fixed Glaucoma Medications
- Other IDs
- GFDU-2011, GANDUO-2011
- Status last verified
- Jan 2011
- First submitted
- 6 Feb 2012
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimatoprost/Timolol Versus Travoprost/Timolol Fixed Combinations in an Egyptian Population: A Hospital-Based Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01542710
- Acronym / sponsor ID
- Fixed Glaucoma Medications
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Mar 2012 (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 compare 2 fixed combination medications in intraocular pressure lowering.
Detailed description
PURPOSE: To compare the efficacy of bimatoprost/timolol (BTFC) or travoprost/timolol (TTFC) fixed combinations on intraocular pressure (IOP) reduction in an Egyptian population.
METHODS: Patients with primary open angle glaucoma (POAG) were randomized to receive either BTFC or TTFC. IOPs were measured at baseline, 2 weeks, and 1, 2, 4, and 6 months. The primary outcome measures were the mean change in IOP from baseline
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma fixed Combination Medications | Experimental | Drug: Ganfort, Drug: Duotrav |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Glaucoma
Key exclusion criteria (1 listed)
- No other ocular diseases
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 |
|---|---|---|
| GanfortAlso: Bimatoprost/Timolol vs Travoprost/Timolol fixed combinationBimatoprost/Timolol fixed combination | Drug | Glaucoma fixed Combination Medications |
| DuotravFixed combination of Travoprost and Timolol | Drug | Glaucoma fixed Combination Medications |
Primary outcome
Percentage of drop of intraocular pressures from baseline.
Time frame: 1 year
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 2 Mar 2012.
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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.
Tamer A Macky, MD FRCS principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganfort and Duotrav in people with Glaucoma, run by Kasr El Aini Hospital at 1 site in Egypt.
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 1 inclusion and 1 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 2 Mar 2012. 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 Egypt. 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.
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 drop of intraocular pressures from baseline. (time frame: 1 year). 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 2 Mar 2012.