Glaucoma, Ocular Hypertension
Conditions
Keywords
observational safety study
Brief summary
Efficacy data was not collected or analyzed. This study did assess safety and tolerability of Xalatan.
Detailed description
* Efficacy data not collected or analyzed * Safety and tolerability of Xalatan assessed NA
Interventions
DRUGXalatan 0.005% eye drops
ophthalmic solution dosed once daily for 3 months
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient with ocular hypertension at least 22mg Hg * Patient must be over 18 years old
Exclusion criteria
* None listed in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | Screening, 10 days, 4 weeks and 12 weeks after beginning treatment | Intraocular pressure was measured at each visit |
| Humphrey Perimetry Visual Field | Visits 1 and 4 | Analysis of visual field deficits for abnormalities. |
Countries
Egypt, Saudi Arabia, United Arab Emirates
Participant flow
Recruitment details
Investigative sites
Participants by arm
| Arm | Count |
|---|---|
| Xalatan 0.005% ophthalmic solution dosed once daily for 3 months | 1,349 |
| Total | 1,349 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 15 |
| Overall Study | Death | 4 |
| Overall Study | Lack of Efficacy | 22 |
| Overall Study | Lost to Follow-up | 40 |
| Overall Study | Other | 163 |
Baseline characteristics
| Characteristic | Xalatan |
|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 13 |
| Sex/Gender, Customized Female | 584 Participants |
| Sex/Gender, Customized Male | 723 Participants |
| Sex/Gender, Customized Unspecified | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 101 / — |
| serious Total, serious adverse events | 5 / — |
Outcome results
Primary
Humphrey Perimetry Visual Field
Analysis of visual field deficits for abnormalities.
Time frame: Visits 1 and 4
Population: 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.
Primary
Intraocular Pressure
Intraocular pressure was measured at each visit
Time frame: Screening, 10 days, 4 weeks and 12 weeks after beginning treatment
Population: 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.