Back to resultsEffect of Intraoperative Dexamethasone on Post-op Dry Eye
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dexamethasone intraocular suspension, 9%
Prednisolone Acetate 1% Oph Susp
Sponsored by
About this trial
This is an interventional prevention trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
- undergoing bilateral cataract surgery
Exclusion Criteria:
- central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye
Sites / Locations
- Hauser Ross Surgical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intracameral dexamethasone 9% + postoperative topical prednisolone acetate
postoperative topical prednisolone acetate
Arm Description
dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively
topical ophthalmic prednisolone acetate for 3 weeks post-operatively
Outcomes
Primary Outcome Measures
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)
Secondary Outcome Measures
Full Information
NCT ID
NCT04184999
First Posted
December 1, 2019
Last Updated
January 31, 2021
Sponsor
SR Cornea Consultants
1. Study Identification
Unique Protocol Identification Number
NCT04184999
Brief Title
Effect of Intraoperative Dexamethasone on Post-op Dry Eye
Official Title
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SR Cornea Consultants
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.
Detailed Description
Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled prospective study.
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intracameral dexamethasone 9% + postoperative topical prednisolone acetate
Arm Type
Experimental
Arm Description
dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively
Arm Title
postoperative topical prednisolone acetate
Arm Type
Active Comparator
Arm Description
topical ophthalmic prednisolone acetate for 3 weeks post-operatively
Intervention Type
Drug
Intervention Name(s)
dexamethasone intraocular suspension, 9%
Other Intervention Name(s)
Dexycu
Intervention Description
single dose intracameral corticosteroid
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate 1% Oph Susp
Intervention Description
topical ophthalmic steroid drop
Primary Outcome Measure Information:
Title
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
Description
Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
undergoing bilateral cataract surgery
Exclusion Criteria:
central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Rao, MD
Organizational Affiliation
SR Cornea Conslutants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hauser Ross Surgical Center
City
Sycamore
State/Province
Illinois
ZIP/Postal Code
60178
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intraoperative Dexamethasone on Post-op Dry Eye
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