CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
KPI-121 0.25% Ophthalmic Suspension +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02245516
NCT02245516N/ACompleted
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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

Kala Pharmaceuticals, Inc.·interventional·Posted Sep 19, 2014·Updated Dec 10, 2020

In Brief

A clinical study evaluating KPI-121 0.25% Ophthalmic Suspension and KPI-121 1.0% Ophthalmic Suspension for Retinal Vein Occlusion and Diabetic Macular Edema. Completed, enrolled 16 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinal Vein Occlusion, Diabetic Macular Edema
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 19, 2014
Enrollment StartJul 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.8 years ago

Interventions

KPI-121 0.25% Ophthalmic Suspensiondrug

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.

KPI-121 1.0% Ophthalmic Suspensiondrug

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.