Back to resultsTopical Tranexamic Acid After Intravitreal Injections
Primary Purpose
Subconjunctival Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Balanced Salt Solution
Sponsored by
About this trial
This is an interventional prevention trial for Subconjunctival Hemorrhage
Eligibility Criteria
Inclusion Criteria:
Subjects receiving intravitreal injections as part of their routine ophthalmological care
Exclusion Criteria:
Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure, active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased risk for thromboembolic events, known sensitivity to the study drug
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Topical tranexamic acid
Topical BSS
Arm Description
Outcomes
Primary Outcome Measures
Subconjunctival hemorrahge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04400916
Brief Title
Topical Tranexamic Acid After Intravitreal Injections
Official Title
Topical Use of Tranexamic Acid for Prevention of Subconjunctival Hemorrhage After Intravitreal Injections
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
We aim to investigate whether topical administration of Tranexamic acid can reduce the occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subconjunctival Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topical tranexamic acid
Arm Type
Experimental
Arm Title
Topical BSS
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
A single drop administered topically
Intervention Type
Other
Intervention Name(s)
Balanced Salt Solution
Intervention Description
A single drop administered topically
Primary Outcome Measure Information:
Title
Subconjunctival hemorrahge
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects receiving intravitreal injections as part of their routine ophthalmological care
Exclusion Criteria:
Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure, active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased risk for thromboembolic events, known sensitivity to the study drug
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Tranexamic Acid After Intravitreal Injections
We'll reach out to this number within 24 hrs