NCT04400916

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

May 20, 2020

Last Update Submit

May 20, 2020

Conditions

Subconjunctival Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Subconjunctival hemorrahge

    3 days

Study Arms (2)

Topical tranexamic acid

EXPERIMENTAL
Drug: Tranexamic acid

Topical BSS

PLACEBO COMPARATOR
Other: Balanced Salt Solution

Interventions

Tranexamic acidDRUG

A single drop administered topically

Topical tranexamic acid
Balanced Salt SolutionOTHER

A single drop administered topically

Topical BSS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects receiving intravitreal injections as part of their routine ophthalmological care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tranexamic AcidHanks Balanced Salt Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending faculty and vitreoretinal surgeon, Department of Ophthalmology

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 26, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

May 26, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share