Ocular Hypertension, Open-angle Glaucoma
Conditions
Keywords
Glaucoma, Open-angle glaucoma, Ocular hypertension, Hypertension, Eye Diseases, Vascular Diseases, Cardiovascular Diseases, Travoprost, Antihypertensive Agents, Cardiovascular Agents, Therapeutic Uses, Pharmacologic Actions
Brief summary
The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.
Interventions
DRUGTravoprost 0.004% BAK-free
Containing Polyquad (PQ) preservative
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye; * On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator; * Intraocular pressure (IOP) \<30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy; * IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period; * Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study; * Able to follow instructions and willing and able to attend all study visits; * Best corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye; * Must sign an 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 deemed clinically significant in the opinion of the Principal Investigator; * Any abnormality preventing reliable applanation tonometry in either eye; * Corneal dystrophies in either eye; * Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye; * Any clinically significant, serious, or severe medical condition; * Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study; * Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids; * 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; * Women who are pregnant, lactating, or not using reliable means of birth control; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) | Baseline, Week 12 | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Reach Target IOP (≤18 mmHg) | Week 12 | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis. |
Participant flow
Recruitment details
Patients were recruited from 4 study centers located in Argentina, 4 study centers located in Chile, and 2 study centers located in Colombia.
Pre-assignment details
This reporting group includes all enrolled patients (191).
Participants by arm
| Arm | Count |
|---|---|
| TRAVATAN® BAK-free Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks. | 191 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Relative reported subject withdrew | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | TRAVATAN® BAK-free |
|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 139 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 191 |
| serious Total, serious adverse events | 0 / 191 |
Outcome results
Primary
Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Time frame: Baseline, Week 12
Population: This analysis population includes all patients who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRAVATAN® BAK-free | Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) | Baseline | 14.8 mmHg | Standard Deviation 3.4 |
| TRAVATAN® BAK-free | Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) | Change from baseline at Week 12 | -1.09 mmHg | Standard Deviation 2.96 |
Secondary
Percentage of Subjects Who Reach Target IOP (≤18 mmHg)
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Time frame: Week 12
Population: This anaylysis population includes all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TRAVATAN® BAK-free | Percentage of Subjects Who Reach Target IOP (≤18 mmHg) | 93.3 percentage of patients |