Open-Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma, OAG, OHT
Brief summary
The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.
Interventions
Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
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. * Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit. * Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator. * 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. * Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye * 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. * Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids. * Any clinically significant, serious, or severe medical condition. * Intraocular conventional surgery or laser surgery in either eye less than three months prior to 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. * Women not using reliable means of birth control. * Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit. * Any clinically significant, serious, or severe medical condition. * Participation in any other investigational study within 30 days of Screening Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 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 Patients With Target IOP (≤18 mmHg) at 12 Weeks | 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
Subjects were recruited from 15 investigative sites located in Europe: Belgium (2); Spain (6); Italy (4); Sweden (3).
Pre-assignment details
Of the 202 subjects enrolled, 1 subject was exited as a screen failure and 2 subjects withdrew consent prior to dosing. This reporting group includes all subjects who instilled at least one dose of the test article (199).
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
Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative | 199 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Inability to Follow Instructions | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 2 |
| Overall Study | Personal Reasons | 4 |
Baseline characteristics
| Characteristic | TRAVATAN® BAK-free |
|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 199 |
| serious Total, serious adverse events | 4 / 199 |
Outcome results
Primary
Mean 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: The Full Analysis Set (FA) included 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 (N=187). Here, n is the number of participants with non-missing values at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRAVATAN® BAK-free | Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) | Baseline | 17.0 millimeters mercury (mmHg) | Standard Deviation 3.3 |
| TRAVATAN® BAK-free | Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) | Change from Baseline at Week 12 (n=178) | -1.16 millimeters mercury (mmHg) | Standard Deviation 2.65 |
Secondary
Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks
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: The Full Analysis Set (FA) included 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 Patients With Target IOP (≤18 mmHg) at 12 Weeks | 81.2 Percentage of participants |