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 range
0 Months – 3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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%.