Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.

February 7, 2024 updated by: Sunir Garg MD, Wills Eye
The purpose of this prospective interventional study is to compare post-intravitreal injection pain between eyes receiving topical bromfenac versus artificial tears as an analgesic after intravitreal injection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This proposed study is a double-masked randomized trial of adult patients receiving bilateral intravitreal injections. Patient data from March 2021 to June 2022 will be collected. Patient pain perception, quantified using the Wong-Baker FACES and the short-form McGill Pain Questionnaire, will be utilized to compare post-intravitreal injection pain between eyes receiving pre-injection bromfenac 0.09% ophthalmic solution versus artificial tears.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • University of Toronto
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Mid Atlantic Retina
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
    • Texas
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria are:

  • Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
  • Clinical indication of bilateral intravitreal anti-vascular endothelial growth factor (VEGF) injection as determined by the treating retina specialist for diseases such as age-related macular degeneration, choroidal neovascularization, diabetic macular edema, diabetic retinopathy, macular edema. proliferative retinopathy, or macular edema associated with retina vein occlusion.
  • Age greater than 18
  • Patient's that have had at least three prior injections in each eye

Exclusion criteria are:

  • Prior ocular surgery (non-cataract)
  • Herpetic eye disease
  • Uncontrolled uveitis
  • Active conjunctivitis, keratitis or keratopathy
  • Current unilateral use of prescription eye drops.
  • Allergy to NSAID

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bromfenac 0.09%
At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent.
Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain
The eyedrop (bromfenac) will be given to the assigned eye.
Placebo Comparator: Artificial Tear
At the time of the injection, the first eye will be randomized to a drop of artificial tear or bromfenac 0.09% and the second eye will receive the other agent.
Drug: Use of artificial tears to reduce intravitreal injection pain
The eyedrop (artificial tears) will be given to the assigned eye.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score
Time Frame: Patients will be asked in the office for their pain rating 5 minutes after injection
Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
Patients will be asked in the office for their pain rating 5 minutes after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
Time Frame: Patients will be asked in the office for their pain rating 5 minutes after injection
Patients will be asked to report their pain on the Wong-Baker Faces pain scale, ranging from 0 through 10, in which 10 is the worst pain level.
Patients will be asked in the office for their pain rating 5 minutes after injection
Change in post-injection pain at 6 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
Time Frame: Patients will be called for their rating 6 hours after injection
Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
Patients will be called for their rating 6 hours after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
Time Frame: Patients will be called for their rating 6 hours after injection
from 0 through 10, in which 10 is the worst pain level.
Patients will be called for their rating 6 hours after injection
Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
Time Frame: Patients will be called for their rating 24 hours after injection
Patients will be asked to report their pain on the Short Form McGill Pain Questionnaire Present Pain Intensity score, ranging from 0 to 5, in which 5 is the worst pain level.
Patients will be called for their rating 24 hours after injection
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
Time Frame: Patients will be called for their rating 24 hours after injection
from 0 through 10, in which 10 is the worst pain level.
Patients will be called for their rating 24 hours after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wills Eye

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 012475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only de-identified data will be shared amongst researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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