Back to resultsA Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery
Primary Purpose
Inflammation Eye
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation Eye
Eligibility Criteria
Inclusion Criteria:
- Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
Exclusion Criteria:
- Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
- Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
- Patients who are known steroid responders
Sites / Locations
- Arizona Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Dexamethasone suspension dose level 1
Dexamethasone suspension dose level 2
Outcomes
Primary Outcome Measures
Anterior Chamber Cell
Number of cells in the anterior chamber
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03687931
Brief Title
A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery
Official Title
A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 26, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iDrop, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Dexamethasone suspension dose level 1
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Dexamethasone suspension dose level 2
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Drop
Primary Outcome Measure Information:
Title
Anterior Chamber Cell
Description
Number of cells in the anterior chamber
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.
Exclusion Criteria:
Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
Patients who are known steroid responders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William White
Organizational Affiliation
iDrop, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery
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