Open-angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Intraocular pressure, Open-angle glaucoma, Ocular hypertension, Adherence, Compliance
Brief summary
The purpose of the study is to compare adherence in patients on a fixed combination of travoprost 0.004%/timolol 0.5% and patients on a concomitant combination of travoprost 0.004% and timolol 0.5% using the Travalert® device.
Interventions
DRUGTravoprost 0.004%/timolol 0.5% fixed combination eye drops (DuoTrav)
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
DRUGTimolol 0.05% eye drops
One drop in the study eye twice daily at 9 a.m. and 9 p.m. for six months using the Travalert device.
DEVICETravalert Dosing Aid
Approved device used with study medication to record time of instillation and quantify dosing
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of open-angle glaucoma or ocular hypertension; * Inadequate control with beta-blocker or prostaglandin monotherapy and starting therapy with travoprost 0.004% and timolol 0.05%; * Intraocular pressure (IOP) at the screening visit in at least one eye ≥ 19 mmHg but not exceeding 36 mmHg in either eye; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Females of childbearing potential currently pregnant, breastfeeding, or not taking control measures to prevent pregnancy; * Not currently receiving treatment for lowering IOP with beta-blockers or prostaglandin analogs; * Currently on therapy or was in therapy with another investigational agent within 30 days prior to the baseline visit; * History of chronic or recurrent severe inflammatory eye disease, or history of ocular trauma within the past six (6) months, or history of ocular infection or ocular inflammation within the past three (3) months in either eye; * History of clinically significant or progressive retinal disease or history of any other severe ocular pathology in either eye that would preclude the administration of a topical prostaglandin analogue; * History of severe or serious hypersensitivity to prostaglandin drugs or their analogues, to topical or systemic beta-blockers, or to any components of the study medication; * Intraocular surgery within the past six (6) months or ocular laser surgery within the past three (3) months as determined by patient history and/or examination in either eye; * Any abnormality preventing reliable applanation tonometry of either eye; * Best-corrected visual acuity worse than 20/30 Snellen in either eye; * Use of any additional topical or systemic ocular hyposensitive medication during the study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 6 months | Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time. |
Countries
Spain
Participant flow
Recruitment details
Patients were recruited from 5 hospitals in Spain.
Pre-assignment details
Baseline characteristics are presented for the per-protocol population.
Participants by arm
| Arm | Count |
|---|---|
| Travalert With Travoprost/Timolol Fixed Combination One drop in the study eye once daily at 9 p.m. for six months using the Travalert device. | 43 |
| Travalert With Travoprost and Timolol One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication. | 42 |
| Total | 85 |
Baseline characteristics
| Characteristic | Travalert With Travoprost/Timolol Fixed Combination | Travalert With Travoprost and Timolol | Total |
|---|---|---|---|
| Age Continuous | 63.8 years STANDARD_DEVIATION 11.1 | 68.6 years STANDARD_DEVIATION 11.8 | 66.2 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 50 |
| serious Total, serious adverse events | 1 / 52 | 1 / 50 |
Outcome results
Primary
Adherence
Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.
Time frame: 6 months
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Travalert With Travoprost/Timolol Fixed Combination | Adherence | 63 percentage of adherent patients |
| Travalert With Travoprost and Timolol | Adherence | 43 percentage of adherent patients |