KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children

Kala Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Ocular Inflammation

Treatments: Drug: KPI-121 1%; Drug: Prednisolone acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03596723

KPI-121-C-010

Details and patient eligibility

About

This study is designed to assess how KPI-121 1% compares to prednisolone acetate in reducing inflammation after cataract surgery in young children. Approximately half the participants will receive KPI-121 1% eye drops and the other half will receive prednisolone acetate.

Enrollment: 2 patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be a candidate for routine, uncomplicated cataract surgery

Exclusion criteria

• Have a post-traumatic cataract.
• Have suspected permanent low vision or blindness in the fellow non-study eye.
• Have active uveitis in either eye.
• Have an ocular neoplasm in either eye.
• Have the presence of viral, bacterial, or fungal disease in either eye.
• Have glaucoma, ocular hypertension, steroid-induced IOP (intraocular pressure) rise or elevated IOP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

2 participants in 2 patient groups

KPI-121 1% BID (twice daily)

Experimental group

Treatment:

Drug: KPI-121 1%

Prednisolone acetate QID (four times daily)

Active Comparator group

Treatment:

Drug: Prednisolone acetate