Status:
COMPLETED
Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema
Lead Sponsor:
Kala Pharmaceuticals, Inc.
Conditions:
Retinal Vein Occlusion
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 suspen...
Eligibility Criteria
Inclusion
- Have documented presence of intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema at Screening
Exclusion
- Treatment with topical, intravitreal injection, posterior sub-Tenon's, or periocular corticosteroids within 120 days prior to Visit 1 and for the duration of the study
- History of uncontrolled glaucoma, IOP over 21 mmHg at Visit 1, or are being treated for glaucoma in the study eye
- Any significant ocular disease that could compromise vision in the study eye (including ongoing ocular infection, wet age-related macular degeneration, myopic degeneration with active subfoveal choroidal neovascularization)
- Known hypersensitivity or contraindication to the investigational product(s) or their components
- Diagnosis of severe/serious ocular condition that in the judgment of the Investigator could confound study assessments or limit compliance; or severe/serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments or limit compliance
- Exposed to an investigational drug within 30 days prior to Visit 1 and for the duration of the study
- In the opinion of the Investigator or study coordinator, an unwillingness or inability to comply with the study protocol or inability to successfully instill eye drops
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02245516
Start Date
July 1 2014
End Date
December 1 2014
Last Update
December 10 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114