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A Phase 3, multicenter, randomized, evaluator-blinded clinical trial to assess the safety and efficacy of Clobetasol propionate ophthalmic nanoemulsion, 0.05% compared to Prednisolone acetate, 1% in the treatment of inflammation after cataract surgery in pediatric population 0 to 3 years of age (CLOSE-3).
EU CTIS ID: 2024-513489-20-00
What this study is testing
To 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%.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
- History of steroid-induced increase in IOP in either eye
- Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically
- Any current corneal abrasion or ulceration
- Known or suspected allergy or hypersensitivity to similar drugs, such as other corticosteroids, or their components
- Patients who have had ocular surgery in the study eye within 90 days prior to surgery
See the full eligibility criteria
Who can join
- 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).
What rules you out
- Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
- History of steroid-induced increase in IOP in either eye
- Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically
- Any current corneal abrasion or ulceration
- Known or suspected allergy or hypersensitivity to similar drugs, such as other corticosteroids, or their components
- Patients who have had ocular surgery in the study eye within 90 days prior to surgery
- History of post-operative unresolved inflammation in the contralateral eye
- Presence or history of chronic generalized systemic disease that the Investigator believes may either increase the risk to the subject or confound the results of the study (e.g., Diabetes mellitus, human immunodeficiency virus [HIV], acquired immunodeficiency syndrome [AIDS]).
- Any concurrent process which, in the opinion of the investigator, could impair patients' safety or limit adherence to the study protocol
- Participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study
- Prior participation in the study described in this protocol unless the patient wasn't randomized
- 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, except for those required for preoperative preparation.
- Systemic administration of any non-steroidal anti inflammatory drugs in the previous 48 hours prior to the surgery, except for those required for preoperative preparation
- Patient or patient's breastfeeding mother who is expected to use corticosteroids (except corticosteroid inhalers and dermatological corticosteroids, as long as they are not used on the eyelids or surrounding area, and oral prednisolone steaglate drops as part of the standard treatment after cataract surgery) or immunosuppressants during the 30 days following cataract surgery
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.