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Multicenter, randomized, evaluator-blinded clinical trial compared to Prednisolone acetate, 1% in the treatment of inflammation and pain after cataract surgery in pediatric population. This study will assess the safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% to that of Prednisolone acetate, 1% when administering one drop four times a day (QID) for 14 days followed by a tapering period of 14 days after cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clobetasol propionate | Experimental | One drop of Clobetasol propionate ophthalmic nanoemulsion, 0.05% will be administered of the study eye QID beginning the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days. |
|
| Prednisolone acetate | Active Comparator | One drop of Prednisolone ophthalmic suspension, 1% will be administered of the study eye QID beginning the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobetasol Propionate | Drug | Clobetasol propionate ophthalmic nanoemulsion 0.05 % is an oil-in-water (O/W), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w). |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%. | Number, frequency, severity, and relationship to IMP of adverse events (AEs) up to last study visit. | Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy on ocular inflammation of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%. | Percentage of patients with anterior chamber inflammation of grade 0. Anterior chamber inflammation is graded on a 5-point scale: 0 = None: Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrique Jimenez | Contact | +34 933946400 | ejimenez@svt.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospìtal Sant Joan de Deu | Recruiting | Barcelona | 08950 | Spain |
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| Prednisolone acetate ophthalmic suspension, 1% | Drug | Microfine sterile ophthalmic suspension of dense and whitish appearance. |
|
| Day 15 |
| Assess the efficacy on pain of Clobetasol propionate ophthalmic nanoemulsion, 0.05% treatment after cataract surgery in pediatric population 0 to 3 years of age, compared to Prednisolone acetate ophthalmic suspension, 1%. | Change in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score. Higher scores mean a worse outcome. Each of the five categories (F) Face; (L) Legs; (A) Activity; (C) Cry; (C) Consolability is scored from 0-2, which results in a total score between zero and ten. | Day 15 |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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