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

NCT05724446 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CLOBOF3-17IA03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Cataract surgery; Inflammation; Pain

Outcome Measures

Primary Outcomes (1)

• 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%.

  Number, frequency, severity, and relationship to IMP of adverse events (AEs) up to last study visit.

  Day 43

Secondary Outcomes (2)

• Assess the efficacy on ocular inflammation 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%.

  Day 15

• Assess the efficacy on pain 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%.

  Day 15

Study Arms (2)

Clobetasol propionate

EXPERIMENTAL

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.

Drug: Clobetasol Propionate

Prednisolone acetate

ACTIVE COMPARATOR

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.

Drug: Prednisolone acetate ophthalmic suspension, 1%

Interventions

Clobetasol Propionate 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).

Also known as: SVT-15473

Clobetasol propionate

Prednisolone acetate ophthalmic suspension, 1% DRUG

Microfine sterile ophthalmic suspension of dense and whitish appearance.

Prednisolone acetate

Eligibility Criteria

• Age: 0 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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 may not qualify 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 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.

Sponsors & Collaborators

• Salvat: lead

Study Sites (1)

Hospìtal Sant Joan de Deu

Barcelona, 08950, Spain

RECRUITING

MeSH Terms

Conditions

Inflammation; Pain

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Enrique Jimenez

CONTACT

+34 933946400; ejimenez@svt.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 13, 2023
• Study Start: December 12, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

ES (1)