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

NCT06130384 | Completed Phase 4 FDA Drug

• 1 other identifier: 012475
• Study Type: interventional
• Target: 97
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Pain; Intravitreal Injection; Pain, Acute

Outcome Measures

Primary Outcomes (6)

• Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score

  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

  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.

  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

  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.

  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

  from 0 through 10, in which 10 is the worst pain level.

  Patients will be called for their rating 24 hours after injection

Study Arms (2)

Bromfenac 0.09%

EXPERIMENTAL

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

Artificial Tear

PLACEBO COMPARATOR

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

Interventions

Use of bromfenac 0.09% to reduce intravitreal injection pain DRUG

The eyedrop (bromfenac) will be given to the assigned eye.

Bromfenac 0.09%

Use of artificial tears to reduce intravitreal injection pain DRUG

The eyedrop (artificial tears) will be given to the assigned eye.

Artificial Tear

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (5)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Mid Atlantic Retina

Bethlehem, Pennsylvania, 18017, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Consultants of San Antonio

San Antonio, Texas, 78240, United States

Location

University of Toronto

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Pain; Acute Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients will be masked. The assistant instilling the eyedrop will be masked to which eyedrop is used for each eye.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Retina Physician and Surgeon, Co-Director of Retina Research

Model Details: All patients will receive both bromfenac 0.09% in the study eye and artificial tears in the control eye. Patients will be randomized to determine whether their right or left eye is the study eye.

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: November 14, 2023
• Study Start: March 1, 2021
• Primary Completion: August 15, 2023
• Study Completion: November 15, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CA (1); US (4)