Glaucoma, Ocular Hypertension
Conditions
Keywords
Xalacom Regulatory post marketing commitment plan safety
Brief summary
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.
Detailed description
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.
Interventions
DRUGLatanoprost-timolol maleate fixed combination ophthalmic solution
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.
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
Healthy volunteers
No
Inclusion criteria
* Patients need to be administered Xalacom® in order to be enrolled in the surveillance.
Exclusion criteria
* Patients not administered Xalacom®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants WithTreatment-Related Adverse Events | Max 104 weeks | 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. |
| Clinical Effectiveness Rate | Max 104 weeks | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | Max 104 weeks | 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 618 |
| Total | 618 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Protocol Violation | 7 |
Baseline characteristics
| Characteristic | Latanoprost/Timolol Maleate |
|---|---|
| Age, Customized >=15 and <65 years | 227 Participants |
| Age, Customized ˃=65 years | 391 Participants |
| Sex: Female, Male Female | 329 Participants |
| Sex: Female, Male Male | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 134 / 618 |
| serious Total, serious adverse events | 13 / 618 |
Outcome results
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).
Time frame: Max 104 weeks
Population: The effectiveness analysis set comprised of participants that were excluded off-label uses or blank evaluation from safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost/Timolol Maleate | Clinical Effectiveness Rate | 82.8 Percentage of participants |
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.
Time frame: Max 104 weeks
Population: The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost/Timolol Maleate | Number of Participants WithTreatment-Related Adverse Events | 73 Participants |
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.
Time frame: Max 104 weeks
Population: The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost/Timolol Maleate | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 3 Participants |