Back to resultsA Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery
Primary Purpose
Cataract in Inflammatory Ocular Disorders
Status
Completed
Phase
Phase 2
Locations
El Salvador
Study Type
Interventional
Intervention
Dexamethasone Dose 1
Dexamethasone Dose 2
Placebo Dose 1
Placebo Dose 2
Sponsored by
About this trial
This is an interventional treatment trial for Cataract in Inflammatory Ocular Disorders
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing traditional cataract surgery.
Exclusion Criteria:
- Patients with unusual ocular conditions.
Sites / Locations
- Centre De. Oftalmologia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Dexamethasone Dose 1
Dexamethasone Dose 2
Placebo Dose 1
Placebo Dose 2
Arm Description
Outcomes
Primary Outcome Measures
Ocular inflammation
Measuring Anterior Cell Count
Secondary Outcome Measures
Ocular Pain
Measuring patient ocular pain using an 11-point visual scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04711213
Brief Title
A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery
Official Title
A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
November 15, 2020 (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 four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.
Detailed Description
"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract in Inflammatory Ocular Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized to 2 active dosing groups and 2 corresponding dosing groups
Masking
Participant
Masking Description
Single Masked randomized study
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone Dose 1
Arm Type
Active Comparator
Arm Title
Dexamethasone Dose 2
Arm Type
Active Comparator
Arm Title
Placebo Dose 1
Arm Type
Placebo Comparator
Arm Title
Placebo Dose 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Dose 1
Intervention Description
Dexamethasone ophthalmic suspension dose 1
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Dose 2
Intervention Description
Dexamethasone ophthalmic suspension dose 2
Intervention Type
Drug
Intervention Name(s)
Placebo Dose 1
Intervention Description
Placebo suspension dose 1
Intervention Type
Drug
Intervention Name(s)
Placebo Dose 2
Intervention Description
Placebo suspension dose 2
Primary Outcome Measure Information:
Title
Ocular inflammation
Description
Measuring Anterior Cell Count
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Ocular Pain
Description
Measuring patient ocular pain using an 11-point visual scale
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing traditional cataract surgery.
Exclusion Criteria:
Patients with unusual ocular conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Casada, MD
Organizational Affiliation
President - Centre De. Oftalmolgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre De. Oftalmologia
City
San Salvador
Country
El Salvador
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery
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