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New treatment option for Cataracts Infantile
Official title Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population
ClinicalTrials.gov ID: NCT05724446
What this study is testing
What is Clobetasol Propionate?
Clobetasol Propionate is an investigational medicine, being studied as a potential treatment for cataracts infantile.
Also referred to as SVT-15473.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 3
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.
You likely can't join if
- 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...
See the full eligibility 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).
- 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 (except corticosteroid inhalers and dermatological corticosteroids, as long as they are not used on the eyelids or surrounding area, and...
- 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...
- 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 assigned by chance.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
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 months to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.