GlaucomaPhase 4NCT00761995
Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension
A Phase 4 study testing Azopt and Cosopt in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in India.
Trial summary
Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in 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, Ocular Hypertension
- What is being tested?
- Azopt and Cosopt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2009to Jul 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
- Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.
- If of child bearing potential
- Must use a reliable means of contraception for the duration of the study or surgically sterilized.
- Must have a negative pregnancy test.
- Must be non-lactating
- IOP measurements ≥ 24 ≤ 36 mm Hg, in at least one eye, at 9.00 a.m and ≥ 21 ≤ 36 mm Hg in at least one eye (the same eye) at 11.00 am measurement
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- The IOP criteria to be met at both time points by the same eye
- Visual Acuity of 6/24 or better in study eye (s)
- Gonioscopy angle of ≥ 2 in the study eye (s)
- Patients with a level of understanding and willingness to fully comply with all visits and study procedures scheduled by the study site as evidenced by written informed consent
Who cannot join
- Patients with one sighted eye or amblyopia
- History of chronic or recurrent uveitis or other inflammatory eye disease (e.g. scleritis).
- History of ocular infections (e.g. conjunctivitis) within past 3 months.
- History of ocular trauma within the past 6 months.
- History of severe or progressive retinal (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease.
- History of severe ocular pathology such as severe glaucoma damage determined by optic nerve head (e.g. C/D ratio > 0.8) or visual field evaluation (e.g. split fixation, clinically significant field loss within the central field) or legal blindness in either eye.
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- Intraocular surgery within the past 12 months or Laser surgery within the past 3 months as determined by patient history and/or examination.
- Any other form of glaucoma other than primary open angle glaucoma.
- Inability to discontinue contact lens wear during the day
- History of hypersensitivity to oral or topical CAIs, sulfonamide drugs or to any component of these medicines.
- Any abnormality preventing reliable applanation tonometry of either eye.
- Patients who are in the investigator's best judgement at risk of visual field or visual acuity worsening as a consequence of participation of trial.
- Chronic use of any systemic medication that may effect IOP with less than one month stable dosing regimen (i.e. sympathomimetic agents, beta-adrenergic blocking agents, alpha agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin-converting enzyme inhibitors, etc.).
- Current use of any ophthalmic, dermatologic or systemic steroid.
- Patients with clinically significant medical (acute or progressive) condition e.g. cardiovascular, pulmonary, hematologic disease or psychiatric illness, who are unlikely to fully complete all protocol requirements as assessed by the investigator.
- Participation in another clinical trial within past 30 days.
- Pregnant and lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Azopt, Cosopt
- Keywords
- Raised IOP
- 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.
AzoptDrug
topical eye drop dosed 1 drop 3 times daily
CosoptDrug
topical eye drop dosed 1 drop 2 times daily
| Study group | Role | What they receive |
|---|---|---|
| Azopt | Active comparator | topical eye drop dosed 1 drop 3 times daily Receives: Drug: Azopt |
| Cosopt | Active comparator | topical eye drop Receives: Drug: Cosopt |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP reduction from baseline at the end of 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
IOP reduction from baseline at the end of 4 and 8 weeks of treatment
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2010
- Study completionJul 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT00761995
- Sponsor's protocol ID
- MA-CT-08-003
- Status last verified
- Jan 2012
- First submitted
- 26 Sep 2008
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00761995
- Acronym / sponsor ID
- MA-CT-08-003
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Raised IOP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 30 Sep 2008 (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.
Safety and Efficacy of Brinzolamide Dosed TID With Dorzolamide Dosed TID in Reducing Intraocular Pressure in Patients With Open Angle Glaucoma or Ocular Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azopt | Active comparator | Drug: Azopttopical eye drop dosed 1 drop 3 times daily |
| Cosopt | Active comparator | Drug: Cosopttopical eye drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.
- If of child bearing potential
- Must have a negative pregnancy test.
- Must be non-lactating
- IOP measurements ≥ 24 ≤ 36 mm Hg, in at least one eye, at 9.00 a.m and ≥ 21 ≤ 36 mm Hg in at least one eye (the same eye) at 11.00 am measurement
Key exclusion criteria (17 listed)
- Patients with one sighted eye or amblyopia
- History of chronic or recurrent uveitis or other inflammatory eye disease (e.g. scleritis).
- History of ocular infections (e.g. conjunctivitis) within past 3 months.
- History of ocular trauma within the past 6 months.
- History of severe or progressive retinal (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease.
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 |
|---|---|---|
| Azopttopical eye drop dosed 1 drop 3 times daily | Drug | Azopt |
| Cosopttopical eye drop dosed 1 drop 2 times daily | Drug | Cosopt |
Primary outcome
IOP reduction from baseline at the end of 12 weeks
Time frame: 12 weeks
1 secondary outcome
IOP reduction from baseline at the end of 4 and 8 weeks of treatment
Time frame: 4 and 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 18 Jul 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.
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 Azopt and Cosopt in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in India.
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 17 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 18 Jul 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 India. 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?
IOP reduction from baseline at the end of 12 weeks (time frame: 12 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 18 Jul 2012.