Primary Open Angle GlaucomaPhase 2NCT01062971
Clinical Study of A Fixed Combination of Timolol-Brimonidine-Dorzolamide
A Phase 2 study testing dorzolamide-timolol-brimonidine in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
To compare intraocular pressure lowering effectiveness of a new fixed combination drug. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- dorzolamide-timolol-brimonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2006to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
- Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).
Who cannot join
- Clinically relevant ophthalmic or systemic conditions may be excluded.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de la Visión. Hospital Universitario La Carlota. Universidad de Montemorelos
Montemorelos, Nuevo León, 67500
About this study
Official title: Comparative Clinical Study of The Safety And Efficacy of A New Fixed-Combination of Timolol-Brimonidine-Dorzolamide In Patients With Open Angle Glaucoma Or Ocular Hypertension
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
Read the detailed description
This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- dorzolamide-timolol-brimonidine
- Keywords
- Open-angle glaucoma, Ocular hypertension, POAG, Treatment
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dorzolamide-timolol-brimonidineDrug
Also called Krytantek Ofteno, Cosopt
Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will received 1 drop twice a day of either formulations.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | IOP Dorzolamide-Timolol-Brimonidine group Receives: Drug: dorzolamide-timolol-brimonidine |
| B | Active comparator | IOP dorzolamide-timolol group Receives: Drug: dorzolamide-timolol-brimonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.
Measured: basal (day 1 ) and final (day 60)
Secondary outcomes (1)
Number of Adverse Events
the numbers of adverse events were quantified by group of studies, the presence of each event was taken as a event.
Measured: basal (day 1 ) and security call (day 75)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startFeb 2006
- Primary completionAug 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Open Angle 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leopoldo M Baiza-Duran, MD, Study director, Clinical Research Department. Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062971
- Sponsor's protocol ID
- SOPHIA-PRO-122
- Status last verified
- May 2018
- First submitted
- 2 Feb 2010
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study of The Safety And Efficacy of A New Fixed-Combination of Timolol-Brimonidine-Dorzolamide In Patients With Open Angle Glaucoma Or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01062971
- Acronym / sponsor ID
- SOPHIA-PRO-122
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Open-angle glaucoma, Ocular hypertension, POAG, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Posted 1 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
Detailed description
This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: dorzolamide-timolol-brimonidineIOP Dorzolamide-Timolol-Brimonidine group |
| B | Active comparator | Drug: dorzolamide-timolol-brimonidineIOP dorzolamide-timolol group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
- Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).
Key exclusion criteria (1 listed)
- Clinically relevant ophthalmic or systemic conditions may be excluded.
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 |
|---|---|---|
| dorzolamide-timolol-brimonidineAlso: Krytantek Ofteno, CosoptPatients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will received 1 drop twice a day of either formulations. | Drug | A, B |
Primary outcome
Intraocular Pressure (IOP)
Time frame: basal (day 1 ) and final (day 60)
the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.
1 secondary outcome
Number of Adverse Events
Time frame: basal (day 1 ) and security call (day 75)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leopoldo M Baiza-Duran, MD study director
Clinical Research Department. Laboratorios Sophia S.A de C.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dorzolamide-timolol-brimonidine in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
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 2 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 1 Aug 2019. 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraocular Pressure (IOP) (time frame: basal (day 1 ) and final (day 60)). 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 1 Aug 2019.