NCT02245516

Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema

An Exploratory, Multi-Center, Randomized, Single-Masked Study Evaluating the Effect of KPI-121 on Intraretinal or Subretinal Fluid Secondary to Retinal Vein Occlusion or Diabetic Macular Edema

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kala Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the study are to evaluate the safety and effect of KPI-121 0.25% ophthalmic suspension and KPI-121 1.0% ophthalmic suspension on intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.

Detailed description

This is a multicenter, randomized, single-masked study evaluating the safety and effect of topical ocular administration of either KPI-121 0.25% ophthalmic suspension or KPI-121 1.0% ophthalmic suspension in subjects with intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.

Conditions

• Retinal Vein Occlusion
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	KPI-121 0.25% Ophthalmic Suspension	KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
DRUG	KPI-121 1.0% Ophthalmic Suspension	KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-09-19
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Locations

2 sites across 1 country: United States