Actively Recruiting
Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population
Led by Salvat · Updated on 2024-09-27
60
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 0 to 3 years old on the day of consent
- Candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens
- Caregiver(s) able and willing to comply with treatment and follow-up procedures
- Signed informed consent from parent(s) or legally authorized representative(s)
- Underwent routine, uncomplicated cataract surgery in one eye with or without intraocular lens
- Clinical evidence of postoperative inflammation (anterior chamber inflammation grade > 0)
You will not qualify if you...
- Presence of any active or suspected viral, bacterial, or fungal disease in the study eye
- Active uveitis in the study eye
- Ocular neoplasia in the study eye
- Post-traumatic cataract in the study eye
- Suspected permanent low vision or blindness in the fellow non-study eye; study eye must not be only good eye
- Use of any topical medication in the study eye within 2 days prior to surgery except for ocular exam or prep
- Systemic steroid anti-inflammatory drugs within 2 weeks prior to surgery
- Systemic non-steroidal anti-inflammatory drugs within 48 hours prior to surgery
- Patient or breastfeeding mother expected to use corticosteroids (except inhalers, dermatological not on eyelids, or oral prednisolone drops) or immunosuppressants during 30 days after surgery
- History of steroid-induced increased intraocular pressure (IOP) in either eye
- Glaucoma, ocular hypertension, or receiving IOP lowering therapy in either eye or systemically
- Any current corneal abrasion or ulceration
- Known or suspected allergy or hypersensitivity to corticosteroids or components
- Ocular surgery in study eye within 90 days prior to surgery
- History of unresolved post-operative inflammation in contralateral eye
- Presence or history of chronic systemic disease increasing risk or confounding results (e.g., diabetes, HIV, AIDS)
- Any condition impairing safety or adherence as judged by investigator
- Participation in investigational drug/device study within 30 days prior or during study
- Prior participation in this study unless patient was not randomized
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospìtal Sant Joan de Deu
Barcelona, Spain, 08950
Actively Recruiting
Research Team
E
Enrique Jimenez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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