GlaucomaPhase 4NCT00981786
24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
A Phase 4 study testing Brimonidine/timolol fixed combination drops added to travoprost and Brinzolamide/timolol fixed combination drops added to travoprost in people with Glaucoma, run by Aristotle University Of Thessaloniki.
Trial summary
The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. Read more about this study
- Who is it for?
- Ages 29 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Brimonidine/timolol fixed combination drops added to travoprost and Brinzolamide/timolol fixed combination drops added to travoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 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 29 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has open-angle glaucoma and is older than 29 years
- Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
- Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
- Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
- Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
- Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
Show all 10Show fewer
- Distance best corrected Snellen visual acuity at least 0.1
- No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
- No history of lack of response (<10% morning IOP reduction) to any medication
- Patient can understand the instructions and adhere to medications
Who cannot join
- Female patient of childbearing potential or lactating mother
- History of trauma, inflammation, surgery
- History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- Signs of ocular infection, except blepharitis
- Evidence of corneal abnormality that may affect IOP measurements etc
- Closed angle
- History of non-compliance
About this study
Official title: Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma
The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.
- Conditions
- Glaucoma
- Being tested
- Brimonidine/timolol fixed combination drops added to travoprost, Brinzolamide/timolol fixed combination drops added to travoprost
- Keywords
- 24-hour IOP control, brinzolamide/timolol, brimonidine/timolol, travoprost
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine/timolol fixed combination drops added to travoprostDrug
Also called Combigan
twice daily administration
Brinzolamide/timolol fixed combination drops added to travoprostDrug
Also called Azarga
twice daily dosing
| Study group | Role | What they receive |
|---|---|---|
| Brinzolamide/Timolol therapy | Active comparator | Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops Receives: Drug: Brimonidine/timolol fixed combination drops added to travoprost; Drug: Brinzolamide/timolol fixed combination drops added to travoprost |
| Brimonidine/Timolol therapy | Active comparator | Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops Receives: Drug: Brimonidine/timolol fixed combination drops added to travoprost; Drug: Brinzolamide/timolol fixed combination drops added to travoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour intraocular pressure
Measured: 3 months
Secondary outcomes (1)
Fluctuation of 24-hour intraocular pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionDec 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.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, AGP Konstas, Aristotle University Of Thessaloniki
- Investigators
- Anastasios G Konstas, MD, PhD, Principal investigator, Glaucoma Unit, 1st University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981786
- Sponsor's protocol ID
- A434
- Status last verified
- Dec 2020
- First submitted
- 16 Sep 2009
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT00981786
- Acronym / sponsor ID
- A434
- Conditions
- Glaucoma
- Keywords
- 24-hour IOP control, brinzolamide/timolol, brimonidine/timolol, travoprost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Aug 2009 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Sep 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 proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brinzolamide/Timolol therapy | Active comparator | Drug: Brimonidine/timolol fixed combination drops added to travoprost, Drug: Brinzolamide/timolol fixed combination drops added to travoprostChronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops |
| Brimonidine/Timolol therapy | Active comparator | Drug: Brimonidine/timolol fixed combination drops added to travoprost, Drug: Brinzolamide/timolol fixed combination drops added to travoprostChronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops |
Who may qualify
- Ages
- 29 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient has open-angle glaucoma and is older than 29 years
- Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
- Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
- Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
- Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
Key exclusion criteria (7 listed)
- Female patient of childbearing potential or lactating mother
- History of trauma, inflammation, surgery
- History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- Signs of ocular infection, except blepharitis
- Evidence of corneal abnormality that may affect IOP measurements etc
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 |
|---|---|---|
| Brimonidine/timolol fixed combination drops added to travoprostAlso: Combigantwice daily administration | Drug | Brimonidine/Timolol therapy, Brinzolamide/Timolol therapy |
| Brinzolamide/timolol fixed combination drops added to travoprostAlso: Azargatwice daily dosing | Drug | Brimonidine/Timolol therapy, Brinzolamide/Timolol therapy |
Primary outcome
Mean 24-hour intraocular pressure
Time frame: 3 months
1 secondary outcome
Fluctuation of 24-hour intraocular pressure
Time frame: 3 months
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 17 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
Anastasios G Konstas, MD, PhD principal investigator
Glaucoma Unit, 1st University Department of Ophthalmology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brimonidine/timolol fixed combination drops added to travoprost and Brinzolamide/timolol fixed combination drops added to travoprost in people with Glaucoma, run by Aristotle University Of Thessaloniki.
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 10 inclusion and 7 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 17 Dec 2020. 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?
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 24-hour intraocular pressure (time frame: 3 months). 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 17 Dec 2020.