Glaucoma,Open-Angle, Ocular Hypertension
Conditions
Brief summary
The primary objective is to evaluate the Intraocular pressure reducing effect of Xalatan over 3 months. The secondary objective is to study the other efficacy parameters during treatment for 3 months
Interventions
OTHERObservational
This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unilateral or bilateral open angle glaucoma or ocular hypertension (IOP (Intraocular Pressure) ≥ 21 mmHg at diagnosis). * Naive patients (no prior anti-glaucoma pharmacological or surgical treatment) and patients with beta-blockers therapy failure * Visual acuity (best corrected) equal to or better than 6/6
Exclusion criteria
* closed/barely open anterior chamber angle or history of acute angle closure glaucoma. * history of any antiglaucoma surgical treatment (Argon Laser Trabeculoplasty and/or any ocular filtering surgical intervention). * ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to baseline visit. (Applies to both fellow and study eyes.) * other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP): Baseline to Month 3 | Baseline, Month 3 | Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Intraocular Pressure (IOP) | Month 1, Month 3 | Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline. |
| Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1, Month 3 | Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change \< 0); Percentage reduction greater than 20% (percentage change \< -20). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Presssure (IOP): Baseline to Month 1 | Baseline, Month 1 | Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Latanoprost All Subjects Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator. | 996 |
| Total | 996 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lack of Efficacy | 9 |
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Other | 18 |
Baseline characteristics
| Characteristic | Latanoprost All Subjects |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 13.4 |
| Sex/Gender, Customized Female | 596 participants |
| Sex/Gender, Customized Male | 395 participants |
| Sex/Gender, Customized Unspecified | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 122 / — |
| serious Total, serious adverse events | 0 / 996 |
Outcome results
Primary
Change in Intraocular Pressure (IOP): Baseline to Month 3
Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between the eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.
Time frame: Baseline, Month 3
Population: Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, \& at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Latanoprost (All Subjects) | Change in Intraocular Pressure (IOP): Baseline to Month 3 | -5.3 mmHg | Standard Deviation 3.9 |
| Latanoprost (no Prior Beta-blocker Therapy) | Change in Intraocular Pressure (IOP): Baseline to Month 3 | -6.8 mmHg | Standard Deviation 3.8 |
| Latanaprost (Prior Beta-blocker Failure) | Change in Intraocular Pressure (IOP): Baseline to Month 3 | -4.1 mmHg | Standard Deviation 3.5 |
Secondary
Categorized Percentage Change in Intraocular Pressure (IOP)
Percentage change=100 times (IOP at observation minus IOP at Baseline) divided by IOP at Baseline. Percentage change in each patient assigned to the following: Increase or no change in IOP (percentage change greater than or equal to 0); Percentage reduction of up to 20% (-20 less than or equal to percentage change \< 0); Percentage reduction greater than 20% (percentage change \< -20).
Time frame: Month 1, Month 3
Population: Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, \& at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported. n=number of participants in each group for that category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Latanoprost (All Subjects) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Increase or no change in IOP | 69 participants |
| Latanoprost (All Subjects) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Percentage reduction of up to 20% | 422 participants |
| Latanoprost (All Subjects) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Percentage reduction of greater than 20% | 491 participants |
| Latanoprost (All Subjects) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Increase or no change in IOP | 62 participants |
| Latanoprost (All Subjects) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Percentage reduction of up to 20% | 312 participants |
| Latanoprost (All Subjects) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Percentage reduction of greater than 20% | 571 participants |
| Latanoprost (no Prior Beta-blocker Therapy) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Percentage reduction of greater than 20% | 300 participants |
| Latanoprost (no Prior Beta-blocker Therapy) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Increase or no change in IOP | 10 participants |
| Latanoprost (no Prior Beta-blocker Therapy) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Increase or no change in IOP | 12 participants |
| Latanoprost (no Prior Beta-blocker Therapy) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Percentage reduction of up to 20% | 90 participants |
| Latanoprost (no Prior Beta-blocker Therapy) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Percentage reduction of up to 20% | 145 participants |
| Latanoprost (no Prior Beta-blocker Therapy) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Percentage reduction of greater than 20% | 264 participants |
| Latanaprost (Prior Beta-blocker Failure) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Percentage reduction of up to 20% | 274 participants |
| Latanaprost (Prior Beta-blocker Failure) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Percentage reduction of greater than 20% | 219 participants |
| Latanaprost (Prior Beta-blocker Failure) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Percentage reduction of greater than 20% | 264 participants |
| Latanaprost (Prior Beta-blocker Failure) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Increase or no change in IOP | 50 participants |
| Latanaprost (Prior Beta-blocker Failure) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 1: Increase or no change in IOP | 58 participants |
| Latanaprost (Prior Beta-blocker Failure) | Categorized Percentage Change in Intraocular Pressure (IOP) | Month 3: Percentage reduction of up to 20% | 217 participants |
Secondary
Percentage Change in Intraocular Pressure (IOP)
Percentage change in IOP calculated as 100 times (IOP at Observation minus IOP at Baseline) divided by IOP at Baseline.
Time frame: Month 1, Month 3
Population: Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, \& at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Latanoprost (All Subjects) | Percentage Change in Intraocular Pressure (IOP) | Month 1 (n=982, 419, 551) | -19.2 percentage change in mmHg | Standard Deviation 20.9 |
| Latanoprost (All Subjects) | Percentage Change in Intraocular Pressure (IOP) | Month 3 (n=945, 402, 531) | -21.5 percentage change in mmHg | Standard Deviation 22.2 |
| Latanoprost (no Prior Beta-blocker Therapy) | Percentage Change in Intraocular Pressure (IOP) | Month 1 (n=982, 419, 551) | -22.6 percentage change in mmHg | Standard Deviation 28 |
| Latanoprost (no Prior Beta-blocker Therapy) | Percentage Change in Intraocular Pressure (IOP) | Month 3 (n=945, 402, 531) | -26.1 percentage change in mmHg | Standard Deviation 29 |
| Latanaprost (Prior Beta-blocker Failure) | Percentage Change in Intraocular Pressure (IOP) | Month 1 (n=982, 419, 551) | -16.5 percentage change in mmHg | Standard Deviation 12.7 |
| Latanaprost (Prior Beta-blocker Failure) | Percentage Change in Intraocular Pressure (IOP) | Month 3 (n=945, 402, 531) | -18.1 percentage change in mmHg | Standard Deviation 14.5 |
Other Pre-specified
Change in Intraocular Presssure (IOP): Baseline to Month 1
Change: IOP at observation minus IOP at baseline. IOP was measured with the non-contact or Goldmann tonometer for a given subject. Three measurements were performed in each eye alternating between eyes, starting with the right eye. The mean of the 3 measurements was used and if both eyes were study eyes, the mean of the 2 eyes was used.
Time frame: Baseline, Month 1
Population: Full Analysis Set (FAS) included all patients who received at least 1 dose of latanoprost (Xalatan®), had baseline IOP recorded, \& at least one postbaseline IOP measure recorded (at either Month 1 or Month 3). No imputation techniques used for missing data; only observed data reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Latanoprost (All Subjects) | Change in Intraocular Presssure (IOP): Baseline to Month 1 | -4.7 mmHg | Standard Deviation 3.4 |
| Latanoprost (no Prior Beta-blocker Therapy) | Change in Intraocular Presssure (IOP): Baseline to Month 1 | -5.9 mmHg | Standard Deviation 3.5 |
| Latanaprost (Prior Beta-blocker Failure) | Change in Intraocular Presssure (IOP): Baseline to Month 1 | -3.7 mmHg | Standard Deviation 3 |