Treatment for inflammation after cataract surgery in young children
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)
This study is testing a new eye drop treatment for reducing inflammation and pain after cataract surgery in young children aged 0 to 3 years.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 0 Months to 3 Years |
| Sex | All |
| Sponsor | Salvat Industry-sponsored |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05724446 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% compared to Prednisolone acetate, 1% in treating inflammation and pain following cataract surgery in children aged 0 to 3 years. It is a multicenter, randomized, evaluator-blinded study where participants will receive one drop of the assigned treatment four times a day for 14 days, followed by a tapering period of 14 days. The study aims to assess the safety and efficacy of the new formulation in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates are children aged 0 to 3 years who are undergoing routine cataract surgery and exhibit clinical evidence of postoperative inflammation.
Not a fit: Patients with active infections, uveitis, or other serious ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing postoperative inflammation in young children undergoing cataract surgery.
How similar studies have performed: Other studies have shown success with similar approaches in managing postoperative inflammation, suggesting potential for this treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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 (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. * 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.
Where this trial is running
Barcelona
- Hospìtal Sant Joan de Deu — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Enrique Jimenez
- Email: ejimenez@svt.com
- Phone: +34 933946400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.