Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Catar… (NCT05724446) | Clinical Trial Compass
RecruitingPhase 3
Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population
Spain60 participantsStarted 2022-12-12
Plain-language summary
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.
Who can participate
Age range0 Months – 3 Years
SexALL
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Inclusion Criteria:
* Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent.
* Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
* Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures.
* Signed informed consent from (ICF) parents or patient's legally authorized representative(s).
* Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens.
* Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade \> 0).
Exclusion Criteria:
* 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. The study eye must not be the patient's only good eye.
* Use of any topical medication in the study eye within 2 days prior to surgery, except for those required for ocular examination or preoperative preparation.
* Systemic administration of any steroidal anti inflammatory drugs in the previous 2 weeks prior to the surgery.
* Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery.
* Patient or patient's breastfeeding mother who is expected to use corticosteroids (ex…
What they're measuring
1
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%.