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The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
All the patients whom an investigator prescribes the first Xalacom® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latan-timolol maleate fixed comb ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost-timolol maleate fixed combination ophthalmic solution | Drug | Xalacom® Combination Eye Drops depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "One drop should be applied to the affected eye(s) once daily". |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants WithTreatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator. | Max 104 weeks |
| Clinical Effectiveness Rate | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks). | Max 104 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator. |
Inclusion Criteria:
Exclusion Criteria:
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The patients whom an investigator involving A6641056 prescribes the Xalacom® Combination Eye Drops.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 661 participants were registered in the study. Of the 661 participants, 28 participants were excluded from the study because their case report forms were not collected. Finally, 633 participants were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Latanoprost/Timolol Maleate | Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 661 participants were registered in the study. 28 participants were excluded from the study because their case report forms were not collected.Of the 633 participants, 15 participants were excluded from the baseline analysis due to following reasons: protocol violation (7 participants) and lost to follow-up (8 participants).
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| ID | Title | Description |
|---|---|---|
| BG000 | Latanoprost/Timolol Maleate | Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants WithTreatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator. | The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once. | Posted | Number | Participants | Max 104 weeks |
|
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The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Latanoprost/Timolol Maleate | Participants received latanoprost/timolol maleate fixed combination eye drops into the affected eye(s) once daily for to a maximum of 104 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ophthalmic herpes zoster | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C571753 | Xalacom |
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|
| Max 104 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Clinical Effectiveness Rate | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks). | The effectiveness analysis set comprised of participants that were excluded off-label uses or blank evaluation from safety analysis set. | Posted | Number | 95% Confidence Interval | Percentage of participants | Max 104 weeks |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator. | The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once. | Posted | Number | Participants | Max 104 weeks |
|
|
|
| 13 |
| 618 |
| 134 |
| 618 |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Age-related macular degeneration | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Blindness | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Retinoschisis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Conjunctivitis bacterial | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Meibomian gland dysfunction | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Age-related macular degeneration | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Corneal erosion | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Blepharal pigmentation | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Conjunctival erosion | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Conjunctival deposit | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Mydriasis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Iritis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Iris hyperpigmentation | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Growth of eyelashes | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Eyelash thickening | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Meibomianitis | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Peripheral artery stenosis | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.