Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Keywords
Open-angle glaucoma, Ocular hypertension, POAG, Treatment
Brief summary
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.
Interventions
DRUGdorzolamide-timolol-brimonidine
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.
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* Clinically relevant ophthalmic or systemic conditions may be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | basal (day 1 ) and final (day 60) | the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | basal (day 1 ) and security call (day 75) | the numbers of adverse events were quantified by group of studies, the presence of each event was taken as a event. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A (Triple Therapy) Dorzolamide-Timolol-Brimonidine group | 56 |
| A (Triple Therapy) Dorzolamide-Timolol-Brimonidine group | 56 |
| B (Doble Therapy) dorzolamide-timolol group | 56 |
| B (Doble Therapy) dorzolamide-timolol group | 56 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Protocol Violation | 1 | 3 |
Baseline characteristics
| Characteristic | A (Triple Therapy) | B (Doble Therapy) | Total |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 10.2 | 59.8 years STANDARD_DEVIATION 12.5 | 60.3 years STANDARD_DEVIATION 9.9 |
| Race/Ethnicity, Customized african | 0 subjects | 1 subjects | 1 subjects |
| Race/Ethnicity, Customized asian | 2 subjects | 1 subjects | 3 subjects |
| Race/Ethnicity, Customized european | 6 subjects | 4 subjects | 10 subjects |
| Race/Ethnicity, Customized hispanic | 48 subjects | 50 subjects | 98 subjects |
| Region of Enrollment Mexico | 56 participants | 56 participants | 112 participants |
| Sex: Female, Male Female | 41 Participants | 42 Participants | 83 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 2 / 56 | 6 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
Intraocular Pressure (IOP)
the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.
Time frame: basal (day 1 ) and final (day 60)
Population: the analysis of the groups was by protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A (Triple Therapy) | Intraocular Pressure (IOP) | baseline | 24.1 mmHg | Standard Deviation 2.6 |
| A (Triple Therapy) | Intraocular Pressure (IOP) | Final | 13.9 mmHg | Standard Deviation 2.9 |
| B (Doble Therapy) | Intraocular Pressure (IOP) | baseline | 23.6 mmHg | Standard Deviation 2.2 |
| B (Doble Therapy) | Intraocular Pressure (IOP) | Final | 16.9 mmHg | Standard Deviation 3.4 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: basal (day 1 ) and security call (day 75)
Population: the analysis of the study groups was done by protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A (Triple Therapy) | Number of Adverse Events | 2 events |
| B (Doble Therapy) | Number of Adverse Events | 6 events |
p-value: >0.05t-test, 2 sided