GlaucomaPhase 4NCT00941096
Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination
A Phase 4 study testing Bimatoprost and Bimatoprost/Timolol fixed combination. in people with Glaucoma and Ocular Hypertension, run by Larissa University Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to examine the ocular hypotensive effect of Bimatoprost and the potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular hypertension, primary open angle glaucoma or exfoliation glaucoma. 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?
- Bimatoprost and Bimatoprost/Timolol fixed combination.
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2009to Nov 2010
- 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
- Primary open angle glaucoma
- Exfoliation glaucoma
- Ocular hypertension
Who cannot join
- Younger than 18 years old
- Inability to understand and/or follow study requirements
- Women of childbearing potential not using reliable birth control, pregnant or lactating women
- History of chronic obstructive pulmonary disease, heart failure, 2nd or 3rd AV block
- Anticipated modification of treatment for systemic hypertension during the study period
- History of ocular herpes, corneal scarring, conventional or laser surgery or macular pathology
Show all 9Show fewer
- History of allergy, poor tolerability or poor response to study medication
- Best corrected visual acuity less than 0.4
- Significant visual field defect (MD<15.0 dB)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of The Bimatoprost/Timolol Fixed Combination In Patients Treated With Bimatoprost for Primary Open Angle Glaucoma, Exfoliation Glaucoma or Ocular Hypertension.
The purpose of this study is to examine the ocular hypotensive effect of Bimatoprost and the potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular hypertension, primary open angle glaucoma or exfoliation glaucoma.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Bimatoprost and Bimatoprost/Timolol fixed combination.
- Keywords
- Glaucoma, Ocular Hypertension, Lumigan, Ganfort
- 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.
Bimatoprost and Bimatoprost/Timolol fixed combination.Drug
Also called Lumigan, Ganfort
Following an appropriate wash-out period, participants were given a 5-week long treatment with Bimatoprost 0.03% once daily in the evening followed by a further 5-week long treatment with the Bimatoprost 0.03%/Timolol 0.5% fixed combination administered in the evening.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal intraocular pressure
Measured: Five weeks on each medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941096
- Sponsor's protocol ID
- 17062009-136
- Status last verified
- Nov 2010
- First submitted
- 16 Jul 2009
- Last updated
- 30 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of The Bimatoprost/Timolol Fixed Combination In Patients Treated With Bimatoprost for Primary Open Angle Glaucoma, Exfoliation Glaucoma or Ocular Hypertension.
- ClinicalTrials.gov ID
- NCT00941096
- Acronym / sponsor ID
- 17062009-136
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular Hypertension, Lumigan, Ganfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 17 Jul 2009 (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 examine the ocular hypotensive effect of Bimatoprost and the potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular hypertension, primary open angle glaucoma or exfoliation glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary open angle glaucoma
- Exfoliation glaucoma
- Ocular hypertension
Key exclusion criteria (9 listed)
- Younger than 18 years old
- Inability to understand and/or follow study requirements
- Women of childbearing potential not using reliable birth control, pregnant or lactating women
- History of chronic obstructive pulmonary disease, heart failure, 2nd or 3rd AV block
- Anticipated modification of treatment for systemic hypertension during the study period
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 |
|---|---|---|
| Bimatoprost and Bimatoprost/Timolol fixed combination.Also: Lumigan, GanfortFollowing an appropriate wash-out period, participants were given a 5-week long treatment with Bimatoprost 0.03% once daily in the evening followed by a further 5-week long treatment with the Bimatoprost 0.03%/Timolol 0.5% fixed combination administered in the evening. | Drug | – |
Primary outcome
Mean diurnal intraocular pressure
Time frame: Five weeks on each medication
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 30 Nov 2010.
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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 Bimatoprost and Bimatoprost/Timolol fixed combination. in people with Glaucoma and Ocular Hypertension, run by Larissa University Hospital at 1 site in Greece.
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 9 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 30 Nov 2010. 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 Greece. 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?
Mean diurnal intraocular pressure (time frame: Five weeks on each medication). 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 30 Nov 2010.