Phase 3
Completed N=79
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
Cataracts · Inflammation
Source: ClinicalTrials.gov NCT01124045 ↗
Enrolled (actual)
79
Serious AEs
24.1%
Results posted
Jun 2013
Primary outcomePrimary: Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days — 78.9; 77.5 Percentage of patients
Summary
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days |
78.9; 77.5 | — |
| SECONDARY Global Assessment Score of Postoperative Inflammation by Visit |
30.8; 17.5; 69.2; 82.5; 0.0; 0.0 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade |
23.7; 40.0; 57.9; 30.0; 15.8; 27.5 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade |
41.0; 45.0; 51.3; 37.5; 7.7; 12.5 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity |
92.3; 87.5; 7.7; 12.5; 0.0; 0.0 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection |
46.2; 25.0; 48.7; 65.0; 2.6; 10.0 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection |
69.2; 57.5; 28.2; 40.0; 0.0; 2.5 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis |
82.1; 85.0; 15.4; 15.0; 0.0; 0.0 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon |
100.0; 100.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis |
100.0; 97.5; 0.0; 2.5; 0.0; 0.0 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity |
100.0; 100.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia |
71.8; 60.0; 20.5; 35.0; 7.7; 5.0 | — |
| SECONDARY Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation |
64.1; 72.5; 30.8; 22.5; 5.1; 5.0 | — |
Eligibility Criteria
Inclusion Criteria
- 0 to 3 years of age.
- Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens.
- Informed consent signed by a parent or legal guardian.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
- Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery.
- Patients with posttraumatic cataract.
- Active uveitis in the study eye.
- Ocular neoplasm in the study eye.
- Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS).
- Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye.
- Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.
- History of steroid-induced intraocular pressure (IOP) rise.
- Currently on medication for ocular hypertension or glaucoma in the study eye.
- Diabetes.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01124045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.