Trial Outcomes & Findings for Long-Term Non-Interventional Latanoprost Study (NCT NCT01265719)
NCT ID: NCT01265719
Last Updated: 2021-02-03
Results Overview
Patients familiar with the letters of the alphabet were evaluated using Snellen visual acuity. Patients who were unable or unfamiliar with the letters of the alphabet were evaluated using charts made up of numbers, pictures (eg, Schering's Children's Eye Chart or Allen Cards), E's, or Landolt's broken rings, and other methods which were equivalent to Snellen acuity eg, HOTV testing).
Recruitment status
COMPLETED
Target enrollment
175 participants
Primary outcome timeframe
Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Results posted on
2021-02-03
Participant Flow
A total of 175 patients were enrolled into the study in 14 countries in Europe and South America: 102 in the latanoprost treatment group and 73 in the non-Prostaglandin (PG) treatment group.
No significant events prior to group assignment are to be reported. This was a non-interventional, prospective, longitudinal cohort study. Pediatric patients with glaucoma or elevated intra ocular pressure (IOP) were enrolled into 2 groups: Latanoprost-treated patients and non-PG treated patients.
Participant milestones
| Measure |
Latanoprost Group
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
73
|
|
Overall Study
COMPLETED
|
88
|
60
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
| Measure |
Latanoprost Group
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Overall Study
Does not meet entrance criteria
|
0
|
3
|
|
Overall Study
Other reasons
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Long-Term Non-Interventional Latanoprost Study
Baseline characteristics by cohort
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.8 Years
STANDARD_DEVIATION 4.96 • n=5 Participants
|
6.4 Years
STANDARD_DEVIATION 4.76 • n=7 Participants
|
7.8 Years
STANDARD_DEVIATION 5.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
Patients familiar with the letters of the alphabet were evaluated using Snellen visual acuity. Patients who were unable or unfamiliar with the letters of the alphabet were evaluated using charts made up of numbers, pictures (eg, Schering's Children's Eye Chart or Allen Cards), E's, or Landolt's broken rings, and other methods which were equivalent to Snellen acuity eg, HOTV testing).
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)
<5 years
|
0.25 logMar
Standard Error 0.17
|
-0.07 logMar
Standard Error 0.09
|
|
Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)
5 to <18 years
|
0.01 logMar
Standard Error 0.02
|
0.04 logMar
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
The refractive error \[cycloplegic where appropriate (eg, those unable to cooperate with manifest refraction)\] were determined at the baseline visit and assessed at the following visits.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Number of Participants With Clinically Meaningful Change in Refractive Error
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
The horizontal corneal diameter was measured along the horizontal meridians. Diameter was measured using either a series of transparent plates with holes of different diameters in quarter-millimeter increments or with calibrated calipers compared against a ruler. When using calipers, the corneal diameter measurement was taken from limbus to a similar point 180° away at the opposite limbus. When not examining the children with anesthesia, it was recommended to use a tape measure across the head while measuring horizontal corneal diameter by photographic method.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)
<5 years
|
0.33 mm
Standard Error 0.22
|
0.37 mm
Standard Error 0.19
|
|
Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)
5 to <18 years
|
0.08 mm
Standard Error 0.12
|
0.05 mm
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
IOP was preferably measured using 1 of 3 applanation-contact methods: Goldmann applanation tonometry, Perkins tonometry, or TonoPen® (tonometry). iCare® rebound tonometer was also allowed if it was used consistently throughout the study.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)
<5 years
|
-1.01 mmHg
Standard Error 0.94
|
0.61 mmHg
Standard Error 0.78
|
|
Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)
5 to <18 years, IOP <21mmHg at Baseline
|
1.52 mmHg
Standard Error 0.43
|
1.62 mmHg
Standard Error 0.61
|
|
Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)
5 to <18 years, IOP ≥21mmHg at Baseline
|
-4.26 mmHg
Standard Error 1.22
|
2.40 mmHg
Standard Error 1.99
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
The cup/disc ratio was recorded horizontally and vertically for each examination, and reported in 0.1 increments.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios
|
1 Participants
Interval -0.11 to 0.62
|
0 Participants
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
A visual field examination was performed for those patients who can cooperate automated perimetry utilizing a threshold program. All visual fields was conducted utilizing the standard white background with a Goldmann size III white stimulus. For those patients who can not perform formal visual field testing, then field to confrontation test was used for younger, non-verbal children, central, steady and maintains fixation was used.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects.
|
1 Participants
Interval -0.11 to 0.62
|
1 Participants
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
Changes from baseline in iris color were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Iris Color Darkening
|
4 Participants
Interval -0.11 to 0.62
|
2 Participants
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
Changes from baseline in localized pigmentation (nevi and freckles) of the conjunctiva, iris and choroid were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid
|
3 Participants
0.17 • Interval -0.11 to 0.62
|
3 Participants
0.09
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
Changes from baseline in eyelash darkening/thickening/lengthening were reported at each follow-up visit. Photographs were taken at the discretion of investigators as per standard of care.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Eyelash Darkening/Thickening
|
3 Participants
Interval -0.11 to 0.62
|
1 Participants
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
The longest eyelash (mm) measured by caliper or ruler was recorded at baseline and each follow-up visit.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)
<5 years
|
1.14 mm
Standard Error 0.40
|
0.53 mm
Standard Error 0.33
|
|
Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)
5 to <18 years
|
0.44 mm
Standard Error 0.19
|
0.65 mm
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
Central corneal thickness was measured using a calibrated pachymeter, preferably an ultrasonic pachymeter.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)
<5 years
|
-8.67 Micrometer
Standard Error 11.51
|
-5.99 Micrometer
Standard Error 10.27
|
|
Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)
5 to <18 years
|
5.30 Micrometer
Standard Error 2.75
|
6.17 Micrometer
Standard Error 4.01
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
Conjunctiva hyperemia was assessed by slit-lamp examination. When slit-lamp examination is not possible due to subject cooperation, a fixation light and 20-diopter lens (for magnification) was used to assess this parameter. Conjunctival hyperemia was assessed and graded by ophthalmologist at baseline and follow-up visits from grades 0-3 and is as follows: 0 = None, Normal: few vessels of palpebral or bulbar conjunctiva easily observed 1. = Mild, Reddening of the palpebral or bulbar conjunctiva 2. = Moderate, Bright reddening of the palpebral or bulbar conjunctiva 3. = Severe, Deep, bright, and diffuse reddening of the palpebral or bulbar conjunctiva
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Conjunctival/Ocular Hyperemia
|
6 Participants
Interval -0.11 to 0.62
|
1 Participants
|
SECONDARY outcome
Timeframe: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 monthsPopulation: The Full Analysis population included all enrolled subjects.
Slit-lamp biomicroscopy (mounted or hand-held) without fluorescein and without dilation of the pupil was performed. When slit-lamp examination was not possible, a fixation light and 20-diopter lens (for magnification) was used. At each scheduled visit, deposition of pigment on the corneal endothelial layer or the lens capsule or any abnormalities of the lids, conjunctivae, cornea, anterior chamber, iris, or lens was examined.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Number of Participants With a Change in Anterior Segment Biomicroscopy
|
0 Participants
0.17 • Interval -0.11 to 0.62
|
0 Participants
0.09
|
SECONDARY outcome
Timeframe: Evaluated at BaselinePopulation: The Full Analysis population included all enrolled subjects.
Fundoscopy was performed after dilation of the pupils (eg, 1 % tropicamide or cyclopentolate and 2 ½ % phenylephrine, or a clinically- appropriate dose according to the clinician's standard care of each particular patient). The examination included an evaluation of the vitreous body, retina (including the macula), and optic nerve head. The fundoscopy e-CRF was completed only at baseline because the investigators were required to perform slit lamp, direct or indirect ophthalmoscopy at each visit and report any AEs observed which included the vitreous, retina and optic nerve.
Outcome measures
| Measure |
Latanoprost Group
n=102 Participants
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=73 Participants
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline
Optic nerve head
|
43 Participants
|
29 Participants
|
|
Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline
Retina macula choroid
|
12 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline
Vitreous body
|
3 Participants
|
1 Participants
|
Adverse Events
Latanoprost Group
Serious events: 11 serious events
Other events: 20 other events
Deaths: 0 deaths
Non Prostaglandin Group
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Latanoprost Group
n=102 participants at risk
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=72 participants at risk
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Developmental glaucoma
|
0.98%
1/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Congenital, familial and genetic disorders
Neurofibromatosis
|
0.98%
1/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Eye disorders
Glaucoma
|
2.0%
2/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Eye disorders
Iris incarceration
|
0.98%
1/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
1.4%
1/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Eye disorders
Retinal detachment
|
0.98%
1/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Infections and infestations
Pilonidal cyst
|
0.98%
1/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Investigations
Intraocular pressure increased
|
2.9%
3/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
1.4%
1/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Investigations
Optic nerve cup/disc ratio increased
|
0.98%
1/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
1.4%
1/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Nervous system disorders
Epilepsy
|
0.98%
1/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
1.4%
1/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Nervous system disorders
Seizure
|
0.98%
1/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Surgical and medical procedures
Eye operation
|
0.00%
0/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
1.4%
1/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
Other adverse events
| Measure |
Latanoprost Group
n=102 participants at risk
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination and treated with latanoprost during the study period.
Patients continuously treated with latanoprost for at least 1 month within 1 year before the baseline examination only.
|
Non Prostaglandin Group
n=72 participants at risk
Patients continuously treated with latanoprost or other topical PG analogues for less than 1 month before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
Patients not treated with latanoprost or other topical PG analogues before the baseline examination, and unlikely to be treated with latanoprost or other topical PG analogues during the study period.
|
|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
4.9%
5/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
1.4%
1/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Eye disorders
Eye pain
|
3.9%
4/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
0.00%
0/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Eye disorders
Iris hyperpigmentation
|
3.9%
4/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
2.8%
2/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
4/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
5.6%
4/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
|
Investigations
Intraocular pressure increased
|
8.8%
9/102 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
12.5%
9/72 • Adverse events were reported from the signing of the informed consent throughout the entire study period or 28 calendar days after the last administration of latanoprost within the observational period, whichever is latest.
One patient was missed in the adverse event raw data; no collection AE start date on case report form page hence the number of participants in Non Prostaglandin group is 72.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER