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The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol etabonate | Experimental | Loteprednol etabonate 0.5% |
|
| Prednisolones acetate | Active Comparator | Prednisolone acetate 1.0% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol etabonate | Drug | 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Inflammation | Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal
| Postoperative Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Cells & Flare | Anterior Chamber Flare (for those subjects that could be examined with a slit lamp): Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Valeant/Bausch & Lomb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Inc | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol Etabonate | Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
| FG001 | Prednisolones Acetate | Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol Etabonate | Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
| BG001 | Prednisolones Acetate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Anterior Chamber Inflammation | Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal
| Proportion of subjects with anterior chamber inflammation | Posted | Mean | 95% Confidence Interval | grade of anterior chamber cells | Postoperative Day 29 |
|
29 days
The period of observation for collection of Adverse Events (AEs) extended from the time the subject's parent/legal guardian gave informed consent until the last study visit, Visit 8 (Postoperative Day 90).
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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 | Loteprednol Etabonate | Loteprednol etabonate 0.5% Loteprednol etabonate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous Disorder | Eye disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amblyopia | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Raimondo | Valeant Pharmaceuticals NA | 9089721885 | denise.raimondo@valeant.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2013 | Apr 11, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2013 | Apr 11, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| Prednisolones acetate | Drug | 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
|
|
| Over all visits 42 days |
Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Prednisolones Acetate | Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. |
|
|
| Secondary | Anterior Chamber Cells & Flare | Anterior Chamber Flare (for those subjects that could be examined with a slit lamp): Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect
| Proportion of subjects with anterior chamber flare. | Posted | Mean | 95% Confidence Interval | Grade of anterior chamber flare | Over all visits 42 days |
|
|
|
| 0 |
| 54 |
| 3 |
| 54 |
| 34 |
| 54 |
| EG001 | Prednisolones Acetate | Prednisolone acetate 1.0% Prednisolones acetate: 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days. | 0 | 53 | 0 | 53 | 23 | 53 |
| Glaucoma | Eye disorders | Non-systematic Assessment |
|
| Bronchiolitis | Eye disorders | Non-systematic Assessment |
|
| cataract | Eye disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Eye Pain | Eye disorders | Non-systematic Assessment |
|
| Eyelid Odema | Eye disorders | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | Non-systematic Assessment |
|
| Ocular hyperemia | Eye disorders | Non-systematic Assessment |
|
| Iridocyclitis | Eye disorders | Non-systematic Assessment |
|
| lacrimation increased | Eye disorders | Non-systematic Assessment |
|
| Strabismus | Eye disorders | Non-systematic Assessment |
|
| Vitreous Disorder | Eye disorders | Non-systematic Assessment |
|
| photophobia | Eye disorders | Non-systematic Assessment |
|
| Suture Related Complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Discomfort | General disorders | Non-systematic Assessment |
|
| Installation Site Pain | General disorders | Non-systematic Assessment |
|
| injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post Procedural Complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Post Capsule Opacification | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| iritis | Eye disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Feeling Hot | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Ear Infection | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis Strepococcal | Infections and infestations | Non-systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |