Glaucoma, Ocular Hypertension
Conditions
Keywords
Prospective, non-interventional, longitudinal, cohort study
Brief summary
This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.
Detailed description
At least 40 subjects in each of the following age groups: 1-\<5 years and 5-\<18 years. No minimum required numbers in the \<1 year age group.
Interventions
OTHERNo intervention other than routine medical care
Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female \<18 years of age (neonates must be at least 36 weeks gestational age). * Diagnosis of pediatric glaucoma or elevated intraocular pressure. * Evidence of a personally signed and dated informed consent document indicating that the subject (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. A signed and dated assent will be required where applicable according to local laws. For treated subjects only: * Continuously treated with latanoprost for at least 1 month within the year prior to the baseline examination. For untreated subjects only: * Continuously treated with latanoprost or other topical prostaglandin analogues for less than one month prior to the baseline examination (based on the best knowledge of treating ophthalmologists), and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period; OR * No prior treatment with latanoprost or other topical prostaglandin analogues, and unlikely to be treated with latanoprost or other topical prostaglandin analogues during the three-year study period.
Exclusion criteria
* Unable/unwilling to comply with protocol. * Pregnant or nursing females at baseline. * For treated subjects only: a history of allergy or hypersensitivity to any of the ingredients contained in latanoprost (e.g., hypersensitivity to benzalkonium chloride).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent) | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler) | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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. |
| Change From Baseline to Last Available Observation in Intraocular Pressure (IOP) | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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. |
| Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | The cup/disc ratio was recorded horizontally and vertically for each examination, and reported in 0.1 increments. |
| Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects. | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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. |
| Iris Color Darkening | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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. |
| Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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. |
| Number of Participants With Clinically Meaningful Change in Refractive Error | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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. |
| Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler) | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | The longest eyelash (mm) measured by caliper or ruler was recorded at baseline and each follow-up visit. |
| Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter) | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | Central corneal thickness was measured using a calibrated pachymeter, preferably an ultrasonic pachymeter. |
| Conjunctival/Ocular Hyperemia | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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 |
| Number of Participants With a Change in Anterior Segment Biomicroscopy | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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. |
| Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline | Evaluated at Baseline | 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. |
| Eyelash Darkening/Thickening | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | 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. |
Countries
Belgium, Colombia, Czechia, Denmark, France, Germany, Greece, Italy, Peru, Portugal, Slovakia, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| 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. | 73 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Does not meet entrance criteria | 0 | 3 |
| Overall Study | Lost to Follow-up | 2 | 7 |
| Overall Study | Other reasons | 2 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 3 |
Baseline characteristics
| Characteristic | Latanoprost Group | Non Prostaglandin Group | Total |
|---|---|---|---|
| Age, Continuous | 8.8 Years STANDARD_DEVIATION 4.96 | 6.4 Years STANDARD_DEVIATION 4.76 | 7.8 Years STANDARD_DEVIATION 5.01 |
| Sex: Female, Male Female | 48 Participants | 28 Participants | 76 Participants |
| Sex: Female, Male Male | 54 Participants | 45 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 102 | 14 / 72 |
| serious Total, serious adverse events | 11 / 102 | 2 / 72 |
Outcome results
Primary
Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent)
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).
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Latanoprost Group | 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 |
| Latanoprost Group | 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 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent) | <5 years | -0.07 logMar | Standard Error 0.09 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Best Corrected Visual Acuity (BCVA) (Snellen or Equivalent) | 5 to <18 years | 0.04 logMar | Standard Error 0.04 |
Comparison: \<5 yearsp-value: 0.112695% CI: [-0.09, 0.74]ANCOVA
Comparison: 5 to \<18 yearsp-value: 0.48495% CI: [-0.12, 0.06]ANCOVA
Secondary
Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter)
Central corneal thickness was measured using a calibrated pachymeter, preferably an ultrasonic pachymeter.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Latanoprost Group | Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter) | <5 years | -8.67 Micrometer | Standard Error 11.51 |
| Latanoprost Group | Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter) | 5 to <18 years | 5.30 Micrometer | Standard Error 2.75 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter) | <5 years | -5.99 Micrometer | Standard Error 10.27 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Corneal Thickness (Pachymeter) | 5 to <18 years | 6.17 Micrometer | Standard Error 4.01 |
Comparison: \<5 yearsp-value: 0.864395% CI: [-34.3, 28.94]ANCOVA
Comparison: 5 to \<18 yearsp-value: 0.859195% CI: [-10.54, 8.8]ANCOVA
Secondary
Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler)
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.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Latanoprost Group | 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 |
| Latanoprost Group | 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 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler) | <5 years | 0.37 mm | Standard Error 0.19 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Horizontal Corneal Diameter (by Caliper and/or Ruler) | 5 to <18 years | 0.05 mm | Standard Error 0.16 |
Comparison: \<5 yearsp-value: 0.90295% CI: [-0.63, 0.56]ANCOVA
Comparison: 5 to \<18 yearsp-value: 0.882695% CI: [-0.37, 0.43]ANCOVA
Secondary
Change From Baseline to Last Available Observation in Intraocular Pressure (IOP)
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.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Latanoprost Group | Change From Baseline to Last Available Observation in Intraocular Pressure (IOP) | <5 years | -1.01 mmHg | Standard Error 0.94 |
| Latanoprost Group | 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 |
| Latanoprost Group | 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 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Intraocular Pressure (IOP) | <5 years | 0.61 mmHg | Standard Error 0.78 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Intraocular Pressure (IOP) | 5 to <18 years, IOP <21mmHg at Baseline | 1.62 mmHg | Standard Error 0.61 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Intraocular Pressure (IOP) | 5 to <18 years, IOP ≥21mmHg at Baseline | 2.40 mmHg | Standard Error 1.99 |
Comparison: \<5 yearsp-value: 0.200395% CI: [-4.13, 0.89]ANCOVA
Comparison: 5 to \<18 years (IOP \<21mmHg at Baseline)p-value: 0.89495% CI: [-1.59, 1.39]ANCOVA
Comparison: 5 to \<18 years (IOP ≥21mmHg at Baseline)p-value: 0.018495% CI: [-11.95, -1.36]ANCOVA
Secondary
Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler)
The longest eyelash (mm) measured by caliper or ruler was recorded at baseline and each follow-up visit.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Latanoprost Group | Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler) | <5 years | 1.14 mm | Standard Error 0.4 |
| Latanoprost Group | 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 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler) | <5 years | 0.53 mm | Standard Error 0.33 |
| Non Prostaglandin Group | Change From Baseline to Last Available Observation in Length of Eyelash (by Caliper and/or Ruler) | 5 to <18 years | 0.65 mm | Standard Error 0.26 |
Comparison: \<5 yearsp-value: 0.243795% CI: [-0.43, 1.65]ANCOVA
Comparison: 5 to \<18 yearsp-value: 0.519995% CI: [-0.85, 0.43]ANCOVA
Secondary
Conjunctival/Ocular Hyperemia
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
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost Group | Conjunctival/Ocular Hyperemia | 6 Participants |
| Non Prostaglandin Group | Conjunctival/Ocular Hyperemia | 1 Participants |
p-value: 0.241395% CI: [-10.49, 19.36]Fisher Exact
Secondary
Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios
The cup/disc ratio was recorded horizontally and vertically for each examination, and reported in 0.1 increments.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost Group | Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios | 1 Participants |
| Non Prostaglandin Group | Cup-to-disc Ratio (for Assessment of Optic Nerve Changes/Structures) - Number of Participants With Clinically Significant Deterioration in Cup/Disc Ratios | 0 Participants |
p-value: >0.99995% CI: [-13.97, 15.9]Fisher Exact
Secondary
Eyelash Darkening/Thickening
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.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost Group | Eyelash Darkening/Thickening | 3 Participants |
| Non Prostaglandin Group | Eyelash Darkening/Thickening | 1 Participants |
p-value: 0.641495% CI: [-13.39, 16.48]Fisher Exact
Secondary
Iris Color Darkening
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.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost Group | Iris Color Darkening | 4 Participants |
| Non Prostaglandin Group | Iris Color Darkening | 2 Participants |
p-value: >0.99995% CI: [-13.78, 16.09]Fisher Exact
Secondary
Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid
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.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Latanoprost Group | Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid | 3 Participants | 0.17 |
| Non Prostaglandin Group | Localized Pigmentation (Nevi or Freckles) of Conjunctiva, Iris and Choroid | 3 Participants | 0.09 |
Secondary
Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline
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.
Time frame: Evaluated at Baseline
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Latanoprost Group | Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline | Vitreous body | 3 Participants |
| Latanoprost Group | Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline | Optic nerve head | 43 Participants |
| Latanoprost Group | Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline | Retina macula choroid | 12 Participants |
| Non Prostaglandin Group | Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline | Vitreous body | 1 Participants |
| Non Prostaglandin Group | Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline | Optic nerve head | 29 Participants |
| Non Prostaglandin Group | Number of Participants With Abnormalities in Fundoscopy Posterior Segment at Baseline | Retina macula choroid | 1 Participants |
Secondary
Number of Participants With a Change in Anterior Segment Biomicroscopy
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.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Latanoprost Group | Number of Participants With a Change in Anterior Segment Biomicroscopy | 0 Participants | 0.17 |
| Non Prostaglandin Group | Number of Participants With a Change in Anterior Segment Biomicroscopy | 0 Participants | 0.09 |
Secondary
Number of Participants With Clinically Meaningful Change in Refractive Error
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.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost Group | Number of Participants With Clinically Meaningful Change in Refractive Error | 8 Participants |
| Non Prostaglandin Group | Number of Participants With Clinically Meaningful Change in Refractive Error | 2 Participants |
Secondary
Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects.
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.
Time frame: Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months
Population: The Full Analysis population included all enrolled subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Latanoprost Group | Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects. | 1 Participants |
| Non Prostaglandin Group | Visual Field Defects - Number of Participants With Clinically Significant Deterioration of Visual Field Defects. | 1 Participants |
p-value: >0.99995% CI: [-15.32, 14.55]Fisher Exact