Glaucoma, Ocular Hypertension
Conditions
Keywords
Glaucoma, Ocular hypertension
Brief summary
The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.
Interventions
Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative
Ophthalmic solution containing benzalkonium chloride (BAK)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment. * Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye. * IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. * Able to follow instructions and be 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 read, sign, and date an Ethics Committee-approved informed consent form. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator. * Any abnormality preventing reliable applanation tonometry in either eye. * Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids. * History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications). * Contact lens wear. * Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit. * Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study. * Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating. * Unwilling to risk the possibility of darkened iris or eyelash changes. * Participation in any other investigational study within 30 days prior to the Screening Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 | Baseline (Day 0), Month 6 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). 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 analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Reached Target IOP at Each Visit | Week 6, Month 3, Month 6 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. |
| Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Baseline (Day 0), Week 6, Month 3, Month 6 | Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. |
| Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Baseline (Day 0), Month 3, Month 6 | Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. |
| Mean Change From Baseline in IOP at Week 6 and Month 3 | Baseline (Day 0), Week 6, Month 3 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. 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 analysis. |
| Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | Baseline (Day 0), Month 3, Month 6 | The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is None of the time and 4 is All of the time. A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health. |
| Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | Baseline (Day 0), Month 3, Month 6 | TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis. |
| Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Baseline (Day 0), Month 3, Month 6 | Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 2 study centers located in Slovenia.
Pre-assignment details
All enrolled subjects were randomized. This reporting group includes all randomized subjects (104). Note: 1 subject randomized to Travatan and 3 subjects randomized to Lumigan did not receive treatment.
Participants by arm
| Arm | Count |
|---|---|
| TRAVATAN One drop to the study eye(s) once a day in the evening for 6 months | 52 |
| LUMIGAN One drop to the study eye(s) once a day in the evening for 6 months | 52 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Noncompliance | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | TRAVATAN | LUMIGAN | Total |
|---|---|---|---|
| Age, Customized 60 or more years | 27 participants | 26 participants | 53 participants |
| Age, Customized Under 60 years | 25 participants | 26 participants | 51 participants |
| Sex: Female, Male Female | 35 Participants | 16 Participants | 51 Participants |
| Sex: Female, Male Male | 17 Participants | 36 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 49 |
| serious Total, serious adverse events | 0 / 51 | 1 / 49 |
Outcome results
Primary
Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). 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 analysis.
Time frame: Baseline (Day 0), Month 6
Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRAVATAN | Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 | Baseline (Day 0) | 24.66 mmHg | Standard Deviation 3.65 |
| TRAVATAN | Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 | Change from Baseline at Month 6, n=46,43 | -7.61 mmHg | Standard Deviation 4.32 |
| LUMIGAN | Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 | Baseline (Day 0) | 24.59 mmHg | Standard Deviation 4.14 |
| LUMIGAN | Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6 | Change from Baseline at Month 6, n=46,43 | -7.35 mmHg | Standard Deviation 3.84 |
Secondary
Mean Change From Baseline in IOP at Week 6 and Month 3
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. 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 analysis.
Time frame: Baseline (Day 0), Week 6, Month 3
Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRAVATAN | Mean Change From Baseline in IOP at Week 6 and Month 3 | Change from Baseline at Week 6, n=46,46 | -7.50 mmHg | Standard Deviation 3.8 |
| TRAVATAN | Mean Change From Baseline in IOP at Week 6 and Month 3 | Change from Baseline at Month 3, n=46,44 | -7.96 mmHg | Standard Deviation 3.71 |
| LUMIGAN | Mean Change From Baseline in IOP at Week 6 and Month 3 | Change from Baseline at Week 6, n=46,46 | -7.02 mmHg | Standard Deviation 3.28 |
| LUMIGAN | Mean Change From Baseline in IOP at Week 6 and Month 3 | Change from Baseline at Month 3, n=46,44 | -7.82 mmHg | Standard Deviation 3.15 |
Secondary
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6
The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is None of the time and 4 is All of the time. A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health.
Time frame: Baseline (Day 0), Month 3, Month 6
Population: This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRAVATAN | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | Baseline (Day 0) | 14.6 units on a scale | Standard Deviation 14.8 |
| TRAVATAN | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | Change from Baseline at Month 3, n=44,43 | -0.3 units on a scale | Standard Deviation 12.2 |
| TRAVATAN | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | Change from Baseline at Month 6, n=44,42 | 0.4 units on a scale | Standard Deviation 16.2 |
| LUMIGAN | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | Baseline (Day 0) | 10.6 units on a scale | Standard Deviation 10.5 |
| LUMIGAN | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | Change from Baseline at Month 3, n=44,43 | 0.0 units on a scale | Standard Deviation 10.4 |
| LUMIGAN | Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6 | Change from Baseline at Month 6, n=44,42 | 1.7 units on a scale | Standard Deviation 14.3 |
Secondary
Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6
TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Time frame: Baseline (Day 0), Month 3, Month 6
Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRAVATAN | Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | Baseline (Day 0) | 10.7 seconds | Standard Deviation 2.7 |
| TRAVATAN | Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | Change from Baseline at Month 3, n=46,44 | -1.6 seconds | Standard Deviation 5.3 |
| TRAVATAN | Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | Change from Baseline at Month 6, n=46,43 | -2.2 seconds | Standard Deviation 3.6 |
| LUMIGAN | Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | Baseline (Day 0) | 11.7 seconds | Standard Deviation 3.2 |
| LUMIGAN | Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | Change from Baseline at Month 3, n=46,44 | -1.8 seconds | Standard Deviation 4 |
| LUMIGAN | Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6 | Change from Baseline at Month 6, n=46,43 | -2.2 seconds | Standard Deviation 5.1 |
Secondary
Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6
Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Time frame: Baseline (Day 0), Month 3, Month 6
Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 3, -1 Grade Change from Baseline | 6 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 3, +2 Grade Change from Baseline | 1 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Baseline, Grade 2 | 0 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 6, -1 Grade Change from Baseline | 4 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 3, 0 Grade Change from Baseline | 36 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 6, 0 Grade Change from Baseline | 31 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Baseline, Grade 1 | 6 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 6, +1 Grade Change from Baseline | 11 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 3, +1 Grade Change from Baseline | 3 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 6, +2 Grade Change from Baseline | 0 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Baseline, Grade 0 | 44 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 6, +2 Grade Change from Baseline | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Baseline, Grade 0 | 39 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Baseline, Grade 1 | 9 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Baseline, Grade 2 | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 3, -1 Grade Change from Baseline | 6 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 3, 0 Grade Change from Baseline | 33 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 3, +1 Grade Change from Baseline | 5 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 3, +2 Grade Change from Baseline | 0 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 6, -1 Grade Change from Baseline | 7 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 6, 0 Grade Change from Baseline | 26 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6 | Month 6, +1 Grade Change from Baseline | 9 participants |
Secondary
Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6
Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Time frame: Baseline (Day 0), Month 3, Month 6
Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Baseline, Grade 0 | 41 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Baseline, Grade 1 | 8 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Baseline, Grade 2 | 1 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | -1 Grade Change from Baseline at Month 3 | 7 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | 0 Grade Change from Baseline at Month 3 | 33 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | +1 Grade Change from Baseline at Month 3 | 6 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | -1 Grade Change from Baseline at Month 6 | 4 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | 0 Grade Change from Baseline at Month 6 | 28 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | +1 Grade Change from Baseline at Month 6 | 13 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | +2 Grade Change from Baseline at Month 6 | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | 0 Grade Change from Baseline at Month 6 | 25 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Baseline, Grade 0 | 39 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | +1 Grade Change from Baseline at Month 3 | 7 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Baseline, Grade 1 | 9 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | +2 Grade Change from Baseline at Month 6 | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | Baseline, Grade 2 | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | -1 Grade Change from Baseline at Month 6 | 7 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | -1 Grade Change from Baseline at Month 3 | 4 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | +1 Grade Change from Baseline at Month 6 | 10 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6 | 0 Grade Change from Baseline at Month 3 | 33 participants |
Secondary
Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit
Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Time frame: Baseline (Day 0), Week 6, Month 3, Month 6
Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | 0 Grade Change from Baseline at Week 6 | 20 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | 0 Grade Change from Baseline at Month 3 | 13 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Baseline, Grade 1 | 9 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +1 Grade Change from Baseline at Month 3 | 25 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +1 Grade Change from Baseline at Week 6 | 23 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +2 Grade Change from Baseline at Month 3 | 6 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | -1 Grade Change from Baseline at Week 6 | 2 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | -1 Grade Change from Baseline at Month 6 | 0 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +2 Grade Change from Baseline at Week 6 | 1 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | 0 Grade Change from Baseline at Month 6 | 20 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Baseline, Grade 2 | 1 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +1 Grade Change from Baseline at Month 6 | 23 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | -1 Grade Change from Baseline at Month 3 | 2 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +2 Grade Change from Baseline at Month 6 | 3 participants |
| TRAVATAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Baseline, Grade 0 | 40 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +2 Grade Change from Baseline at Month 6 | 2 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Baseline, Grade 0 | 31 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Baseline, Grade 1 | 17 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | Baseline, Grade 2 | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | -1 Grade Change from Baseline at Week 6 | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | 0 Grade Change from Baseline at Week 6 | 23 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +1 Grade Change from Baseline at Week 6 | 20 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +2 Grade Change from Baseline at Week 6 | 2 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | -1 Grade Change from Baseline at Month 3 | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | 0 Grade Change from Baseline at Month 3 | 15 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +1 Grade Change from Baseline at Month 3 | 26 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +2 Grade Change from Baseline at Month 3 | 2 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | -1 Grade Change from Baseline at Month 6 | 1 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | 0 Grade Change from Baseline at Month 6 | 15 participants |
| LUMIGAN | Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit | +1 Grade Change from Baseline at Month 6 | 25 participants |
Secondary
Percentage of Subjects Who Reached Target IOP at Each Visit
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.
Time frame: Week 6, Month 3, Month 6
Population: This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TRAVATAN | Percentage of Subjects Who Reached Target IOP at Each Visit | Week 6, n=46,46 | 69.6 percentage of participants |
| TRAVATAN | Percentage of Subjects Who Reached Target IOP at Each Visit | Month 3, n=46,44 | 71.7 percentage of participants |
| TRAVATAN | Percentage of Subjects Who Reached Target IOP at Each Visit | Month 6, n=46,43 | 73.9 percentage of participants |
| LUMIGAN | Percentage of Subjects Who Reached Target IOP at Each Visit | Week 6, n=46,46 | 56.5 percentage of participants |
| LUMIGAN | Percentage of Subjects Who Reached Target IOP at Each Visit | Month 3, n=46,44 | 70.5 percentage of participants |
| LUMIGAN | Percentage of Subjects Who Reached Target IOP at Each Visit | Month 6, n=46,43 | 67.4 percentage of participants |