Ocular Hypertension, Open-Angle Glaucoma
Conditions
Keywords
Glaucoma, Intraocular pressure, Tonometry, ocular
Brief summary
The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.
Detailed description
At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.
Interventions
DRUGBrinzolamide 1.0% + Timolol 0.5% ophthalmic suspension
DRUGDorzolamide 2.0% + Timolol 0.5% ophthalmic solution
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of ocular hypertension, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes. * On a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening Visit. * IOP considered safe (in the opinion of the Investigator) in both eyes in such a way that assures clinical stability of vision and the optic nerve throughout the study period. * IOP between 19 and 35 millimeters mercury (mmHg) in at least one eye (study eye). * Willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study. * Able to follow instructions and willing and able to attend all study visits. * Read, sign, and date an Ethics Committee reviewed and approved Informed Consent Form. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator. * Best corrected visual acuity worse than 20/80 Snellen in either eye. * Any abnormality preventing reliable applanation tonometry in either eye. * Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit. * Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the Investigator's best judgment. * Progressive retinal or optic nerve disease from any cause. * History of ocular herpes simplex. * Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe administration of a topical beta-blocker. * Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. * Women who are pregnant, lactating, or of childbearing potential and not using a reliable means of birth control. * Participation in any other investigational study within 30 days prior to the Screening/baseline Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preferred Treatment | At the end of both periods, Day 15 | The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer? Preferred treatment is presented as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Discomfort | Day 7 of each period | Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort). |
Participant flow
Recruitment details
Participants were recruited from 11 study centers located in Europe.
Pre-assignment details
This reporting group includes all enrolled participants as treated.
Participants by arm
| Arm | Count |
|---|---|
| AZARGA/COSOPT 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods. | 54 |
| COSOPT/AZARGA 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods. | 54 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, First 7 Days | Adverse Event | 1 | 0 |
| Period 1, First 7 Days | Personal Reasons | 1 | 0 |
| Period 2, Second 7 Days | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | AZARGA/COSOPT | COSOPT/AZARGA | Total |
|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 10.1 | 65.0 years STANDARD_DEVIATION 11.92 | 66.3 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 38 Participants | 31 Participants | 69 Participants |
| Sex: Female, Male Male | 16 Participants | 23 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 112 | 0 / 112 |
| serious Total, serious adverse events | 0 / 112 | 0 / 112 |
Outcome results
Primary
Preferred Treatment
The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer? Preferred treatment is presented as a percentage.
Time frame: At the end of both periods, Day 15
Population: This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZARGA | Preferred Treatment | 60.2 Percentage of participants |
| COSOPT | Preferred Treatment | 39.8 Percentage of participants |
Secondary
Ocular Discomfort
Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).
Time frame: Day 7 of each period
Population: This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated, minus any missing responses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZARGA | Ocular Discomfort | 2.6 Units on a scale | Standard Deviation 2.27 |
| COSOPT | Ocular Discomfort | 3.7 Units on a scale | Standard Deviation 2.63 |