Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| This is N/A due to the above description. | This is N/A due to the above description. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | This is a non-interventional study. Subgroups of naïve patients and patients with previous failure to beta-blockers therapy were analyzed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 1, Month 3 |
| Categorized Percentage Change in Intraocular Pressure (IOP) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 1 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
outpatients with unilateral or bilateral open angle glaucoma or ocular hypertension
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Latanoprost All Subjects | Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Latanoprost All Subjects | Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 3 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Latanoprost All Subjects | Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal sensation in eye | Eye disorders | MedDRA (v11.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
| Month 1, Month 3 |
| Other |
|
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG001 | Latanoprost (no Prior Beta-blocker Therapy) | Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator. |
| OG002 | Latanaprost (Prior Beta-blocker Failure) | Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage change in mmHg | Month 1, Month 3 |
|
|
|
| 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). | 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. | Posted | Number | participants | Month 1, Month 3 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 1 |
|
|
|
| 0 |
| 996 |
| 122 |
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
|
| Conjunctival irritation | Eye disorders | Systematic Assessment |
|
| Conjunctival oedema | Eye disorders | Systematic Assessment |
|
| Conjunctival pigmentation | Eye disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Eyelash discolouration | Eye disorders | Systematic Assessment |
|
| Keratoconjunctivitis sicca | Eye disorders | Systematic Assessment |
|
| Sicca syndrome | Eye disorders | Systematic Assessment |
|
| Visual disturbance | Eye disorders | Systematic Assessment |
|
| Adverse event | General disorders | Systematic Assessment |
|
| Blood pressure decreased | Investigations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Hyperaemia | Vascular disorders | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
|
|
| Month 1: Percentage reduction of greater than 20% |
|
| Month 3: Increase or no change in IOP |
|
| Month 3: Percentage reduction of up to 20% |
|
| Month 3: Percentage reduction of greater than 20% |
|