| 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). | The Full Analysis population included all enrolled subjects. | Posted | | Least Squares Mean | Standard Error | logMar | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| <5 years | - ParticipantsOG0004
- ParticipantsOG00116
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | 0.1126 | | LS Mean difference | 0.33 | Standard Error of the Mean | 0.20 | 2-Sided | 95 | -0.09 | 0.74 | | | Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate. | | Superiority or Other (legacy) | | | |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Least Squares Mean | Standard Error | mm | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Least Squares Mean | Standard Error | mmHg | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Least Squares Mean | Standard Error | mm | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Least Squares Mean | Standard Error | Micrometer | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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
- = Mild, Reddening of the palpebral or bulbar conjunctiva
- = Moderate, Bright reddening of the palpebral or bulbar conjunctiva
- = Severe, Deep, bright, and diffuse reddening of the palpebral or bulbar conjunctiva
| The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline, 6 months, 12 months, 24 months and 36 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The Full Analysis population included all enrolled subjects. | Posted | | Number | | Participants | | Evaluated at Baseline | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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