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| ID | Type | Description | Link |
|---|---|---|---|
| A6111128 |
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Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug - Xalatan 0.005% eye drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xalatan 0.005% eye drops | Drug | ophthalmic solution dosed once daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure | Intraocular pressure was measured at each visit | Screening, 10 days, 4 weeks and 12 weeks after beginning treatment |
| Humphrey Perimetry Visual Field | Analysis of visual field deficits for abnormalities. | Visits 1 and 4 |
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Inclusion Criteria:
Exclusion Criteria:
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adults with glauocma or ocular hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Alexandria | Egypt | ||||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Investigative sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Xalatan | 0.005% ophthalmic solution dosed once daily for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Xalatan | 0.005% ophthalmic solution dosed once daily for 3 months |
| 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 | Intraocular Pressure | Intraocular pressure was measured at each visit | Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries. | Posted | Screening, 10 days, 4 weeks and 12 weeks after beginning treatment |
|
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xalatan | 0.005% ophthalmic solution dosed once daily for 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iridocyclitis | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA v11.1 | Systematic Assessment |
Efficacy data were not summarized or analyzed because data collection did not permit clear identification of IOP & visual field data in this non-monitored observational study. Consequently, data were not sufficiently interpretable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Not provided
| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Jeddah |
| Saudi Arabia |
| Pfizer Investigational Site | Umm Al Quwain City | United Arab Emirates |
| Lost to Follow-up |
|
| Other |
|
| years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Primary | Humphrey Perimetry Visual Field | Analysis of visual field deficits for abnormalities. | Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries. | Posted | Visits 1 and 4 |
|
|
| 5 |
| 101 |
| Retinal detachment | Eye disorders | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypoglycaemic coma | Nervous system disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Conjunctival follicles | Eye disorders | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Corneal erosion | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Eye disorder | Eye disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Glaucoma | Eye disorders | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
|
| Uveitis | Eye disorders | Systematic Assessment |
|
| Condition aggravated | General disorders | Systematic Assessment |
|
| Drug effect decreased | General disorders | Systematic Assessment |
|
| Drug ineffective | General disorders | Systematic Assessment |
|
| Ill-defined disorder | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Human ehrlichiosis | Infections and infestations | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperaemia | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth 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.
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |