Normal Tension Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma, Ocular hypertension
Brief summary
The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.
Interventions
benzalkonium chloride (BAC) free
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of normal tension glaucoma. * Must sign an Informed Consent form. * IOP within protocol-specified range. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Pregnant and lactating women, or women who intend to become pregnant during the study period. * Advanced and serious glaucoma, as specified in protocol. * Complicated chronic or recurrent uveitis, scleritis or corneal herpes. * History of ocular trauma, intraocular surgery or laser surgery for the included eye. * Ocular-infection and severe ocular complication. * Best-corrected visual acuity (BCVA) worse than 0.2 decimal. * Difficulty in conducting applanation tonometry for the included eye as determined by the doctor. * Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study. * Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period. * Use of any adrenocorticosteroids during the study period. * Use of IOP lowering ophthalmic solution within the past 30 days. * Regarded by doctor as not suitable for study participation. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 | Baseline (Day 0), Week 4, Week 8, Week 12 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis. |
Countries
Japan
Participant flow
Recruitment details
Subjects were recruited from 5 study sites located in Japan.
Pre-assignment details
This reporting group includes all enrolled subjects (32).
Participants by arm
| Arm | Count |
|---|---|
| TRAVATAN Z Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Change in residence | 1 |
Baseline characteristics
| Characteristic | TRAVATAN Z |
|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 11.1 |
| Baseline IOP 1:00 PM | 15.72 mmHg STANDARD_DEVIATION 1.82 |
| Baseline IOP 5:00 PM | 15.73 mmHg STANDARD_DEVIATION 2.17 |
| Baseline IOP 9:00 AM | 16.55 mmHg STANDARD_DEVIATION 1.43 |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.
Time frame: Baseline (Day 0), Week 4, Week 8, Week 12
Population: This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| TRAVATAN Z | Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 | Baseline | 16.55 mmHg |
| TRAVATAN Z | Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 | Change from Baseline | -3.37 mmHg |