Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population

NCT ID: NCT05724446

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Cataracts Infantile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Clobetasol propionate

One drop of Clobetasol propionate ophthalmic nanoemulsion, 0.05% will be administered of the study eye QID beginning the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days.

Group Type: EXPERIMENTAL

Clobetasol Propionate

Intervention Type: DRUG

Clobetasol propionate ophthalmic nanoemulsion 0.05 % is an oil-in-water (O/W), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w).

Prednisolone acetate

One drop of Prednisolone ophthalmic suspension, 1% will be administered of the study eye QID beginning the day after surgery (Day 1) for 14 days followed by a tapering period of 14 days.

Group Type: ACTIVE_COMPARATOR

Prednisolone acetate ophthalmic suspension, 1%

Intervention Type: DRUG

Microfine sterile ophthalmic suspension of dense and whitish appearance.

Interventions

Clobetasol Propionate

Clobetasol propionate ophthalmic nanoemulsion 0.05 % is an oil-in-water (O/W), clear or slightly yellowish nanoemulsion containing the active ingredient clobetasol propionate at a concentration of 0.05% weight per weight (w/w).

Intervention Type: DRUG

Prednisolone acetate ophthalmic suspension, 1%

Microfine sterile ophthalmic suspension of dense and whitish appearance.

Intervention Type: DRUG

Other Intervention Names

SVT-15473

Eligibility 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.

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salvat

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospìtal Sant Joan de Deu

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Enrique Jimenez

Role: CONTACT

ejimenez@svt.com

+34 933946400

Facility Contacts

Marta Morales, MD

Role: primary

Other Identifiers

CLOBOF3-17IA03

Identifier Type: -

Identifier Source: org_study_id