Intraocular Pressure
Conditions
Keywords
IOP lowering efficacy and safety of Azopt plus Travatan
Brief summary
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
Interventions
DRUGTravoprost 0.004% + Brinzolamide 1.0%
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
DRUGTravoprost 0.004% + Tears Natural
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years; * CACG (Chronic Angle Closure Glaucoma) ≥ 1eye * have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes * clinical stability of VA (Visual Acuity) and optic nerve throughout the study
Exclusion criteria
* Abnormality restricts exam of the fundus or anderior chamber * conjunctivitis, keratitis or uveitis * unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks * ocular surgery prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean IOP (Intraocular Pressure) | Screening: Week 12; (At 9 am and 4 pm time points) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Travoprost 0.004% + Brinzolamide 1.0% Travoprost 0.004% + Brinzolamide 1.0% | 19 |
| Travoprost 0.004% + Tears Natural Travoprost 0.004% + Tears Natural | 18 |
| Total | 37 |
Baseline characteristics
| Characteristic | Travoprost 0.004% + Brinzolamide 1.0% | Travoprost 0.004% + Tears Natural | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 3 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 18 |
Outcome results
Primary
Mean IOP (Intraocular Pressure)
Time frame: Screening: Week 12; (At 9 am and 4 pm time points)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Travoprost 0.004% + Brinzolamide 1.0% | Mean IOP (Intraocular Pressure) | 9 AM measurement | 17.58 mm Hg (millimeters mercury) | Standard Deviation 4.29 |
| Travoprost 0.004% + Brinzolamide 1.0% | Mean IOP (Intraocular Pressure) | 4 PM measurement | 17.11 mm Hg (millimeters mercury) | Standard Deviation 4.5 |
| Travoprost 0.004% + Tears Natural | Mean IOP (Intraocular Pressure) | 9 AM measurement | 20.59 mm Hg (millimeters mercury) | Standard Deviation 3.7 |
| Travoprost 0.004% + Tears Natural | Mean IOP (Intraocular Pressure) | 4 PM measurement | 18.50 mm Hg (millimeters mercury) | Standard Deviation 3.05 |