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The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost | Experimental | Travoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months |
|
| Timolol | Active Comparator | Timolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost 0.004% PQ ophthalmic solution | Drug |
| ||
| Timolol, 0.5% or 0.25% ophthalmic solution |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in IOP at Month 3 | IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis. | Baseline (Day 0), Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Subha Venkataraman, Clinical Project Lead | Alcon Research | Study Director |
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Of the 184 enrolled, 32 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (152).
Participants were recruited from 38 investigational centers in the United States, Germany, Singapore, United Kingdom, Taiwan, Philippines, Spain, Saudi Arabia, Colombia, France, Portugal, Belgium, Poland, Romania, Puerto Rico, and Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost | 1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months |
| FG001 | Timolol | 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Patients 2 months to < 3 years of age received 0.25% |
|
| Travoprost Vehicle | Drug | Inactive ingredients used to maintain masking |
|
| COMPLETED |
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| NOT COMPLETED |
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This analysis population includes all participants who received study drug and completed at least 1 scheduled on-therapy visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Travoprost | 1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months |
| BG001 | Timolol | 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Intraocular Pressure | Mean | Standard Deviation | mmHg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in IOP at Month 3 | IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis. | All participants who received study drug and completed at least 1 scheduled on-therapy visit. No imputation was used, therefore the analysis included only observed cases. | Posted | Mean | Standard Error | mmHg | Baseline (Day 0), Month 3 |
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Adverse events (AEs) were collected for the duration of the study (05 Sep 2012 - 25 Mar 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of whether or not the event has a causal relationship with the medication. All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Treatment | All enrolled participants | 0 | 184 | 1 | 184 | ||
| EG001 | Travoprost | All participants who received travoprost with vehicle | 0 | 77 | 22 | 77 | ||
| EG002 | Timolol | All participants who received timolol; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group. | 2 | 75 | 6 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Keratitis bacterial | Infections and infestations | medDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | medDRA (15.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | medDRA (15.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | medDRA (15.0) | Systematic Assessment |
| |
| Growth of eyelashes | Eye disorders | medDRA (15.0) | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | medDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | medDRA (15.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Subha Venkataraman, Clinical Project Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D006871 | Hydrophthalmos |
| ID | Term |
|---|---|
| D005124 | Eye Abnormalities |
| D005128 | Eye Diseases |
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D013999 | Timolol |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| Title | Measurements |
|---|---|
|
| 12 to <18 years |
|
| Male |
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