Clobetasol propionate for Postoperative ocular inflammation and pain

Inclusion criteria

• {"criterion_text":"- Male or female, aged 0 to 3 years old (have not had their 4th birthday) on the day of consent."}
• {"criterion_text":"- Patients who are candidate for routine, uncomplicated cataract surgery in one eye with or without intraocular lens."}
• {"criterion_text":"- Patients whose caregiver(s) is/are able and willing to comply with all treatment and follow-up procedures"}
• {"criterion_text":"- Signed informed consent from (ICF) parents or patient's legally authorized representative(s)."}
• {"criterion_text":"- Patients who have undergone routine, uncomplicated cataract surgery in one eye with or without intraocular lens."}
• {"criterion_text":"- Patients with clinical evidence of postoperative inflammation (anterior chamber inflammation grade > 0)."}

Exclusion criteria

• {"criterion_text":"- Presence of any active or suspected viral, bacterial, or fungal disease in the study eye."}
• {"criterion_text":"- History of steroid-induced increase in IOP in either eye"}
• {"criterion_text":"- Patients with glaucoma, ocular hypertension, or those receiving IOP lowering therapy in either eye or systemically"}
• {"criterion_text":"- Any current corneal abrasion or ulceration"}
• {"criterion_text":"- Known or suspected allergy or hypersensitivity to similar drugs, such as other corticosteroids, or their components"}
• {"criterion_text":"- Patients who have had ocular surgery in the study eye within 90 days prior to surgery"}
• {"criterion_text":"- History of post-operative unresolved inflammation in the contralateral eye"}
• {"criterion_text":"- 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])."}
• {"criterion_text":"- Any concurrent process which, in the opinion of the investigator, could impair patients' safety or limit adherence to the study protocol"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Prior participation in the study described in this protocol unless the patient wasn't randomized"}
• {"criterion_text":"- Active uveitis in the study eye"}
• {"criterion_text":"- Ocular neoplasia in the study eye"}
• {"criterion_text":"- Post-traumatic cataract in the study eye"}
• {"criterion_text":"- Suspected permanent low vision or blindness in the fellow non-study eye. The study eye must not be the patient's only good eye"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Systemic administration of any steroidal anti inflammatory drugs in the previous 2 weeks prior to the surgery, except for those required for preoperative preparation."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Number, frequency, severity and relationship to IMP of adverse events (AEs) up to last study visit","definition_or_measurement_approach":"Collect and report AEs (number, frequency, severity and investigator-assessed relationship to investigational medicinal product) occurring up to the last study visit."}
• {"endpoint_text":"- Number, frequency, severity and relationship to IMP of Serious AE (SAEs) up to last study visit","definition_or_measurement_approach":"Collect and report Serious Adverse Events (number, frequency, severity and investigator-assessed relationship to IMP) up to the last study visit."}
• {"endpoint_text":"- Proportion of patients discontinuing the study due to AEs","definition_or_measurement_approach":"Proportion (percentage) of randomized patients who discontinue the study because of adverse events, tracked through study completion."}
• {"endpoint_text":"- Proportion of patients discontinuing the study due to lack of efficacy","definition_or_measurement_approach":"Proportion (percentage) of randomized patients who discontinue due to lack of efficacy, tracked through study completion."}
• {"endpoint_text":"- Change from baseline to each study visit in intraocular pressure (IOP)","definition_or_measurement_approach":"Change in measured intraocular pressure from baseline at each scheduled visit."}
• {"endpoint_text":"- Change from baseline to each study visit in visual acuity and physical and eye examination parameters","definition_or_measurement_approach":"Change from baseline in visual acuity and other physical and ocular exam parameters assessed at each visit."}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with anterior chamber inflammation of grade 0 at Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).","definition_or_measurement_approach":"Proportion of patients achieving anterior chamber inflammation grade 0 at specified visits (Day 8±2, 15±2, 29±2, 43±3)."}
• {"endpoint_text":"- Change from baseline to Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3) in the proportion of patients with different grades of anterior chamber inflammation","definition_or_measurement_approach":"Change in distribution/proportion of anterior chamber inflammation grades from baseline to the specified visits."}
• {"endpoint_text":"- Proportion of patients with Grade 1, Grade 2, Grade 3 and Grade 4 of anterior chamber inflammation at Visit 1 (Day 1), Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).","definition_or_measurement_approach":"Proportion of patients in each anterior chamber inflammation grade at baseline and each specified visit."}
• {"endpoint_text":"- Frequency of different signs and symptoms of ocular inflammation at baseline, Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3).","definition_or_measurement_approach":"Frequency counts of various ocular inflammation signs/symptoms at baseline and specified visits."}
• {"endpoint_text":"- Change from baseline to Visit 2 (Day 8±2), Visit 3 (Day 15±2), Visit 4 (Day 29±2) and Visit 5 (Day 43±3) in the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale Score","definition_or_measurement_approach":"Change in FLACC behavioral pain scale score from baseline to the specified visits."}

Spain

Earliest CTIS Part Ii Submission Date

05-04-2024

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

690

Number Of Sites

8

Number Of Participants

60

Primary sponsor

Full Name

Laboratorios Salvat S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain