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

• Sponsor: Wills Eye (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06130384
• Collaborator: (none)
• Enrollment: 139
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 32.5
• Patients Per Site: 27.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Intravitreal Injection; Pain, Acute	Drug: Use of bromfenac 0.09% to reduce intravitreal injection pain; Drug: Use of artificial tears to reduce intravitreal injection pain	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Double (Participant, Care Provider)
• Masking Description: Patients will be masked. The assistant instilling the eyedrop will be masked to which eyedrop is used for each eye.
• Primary Purpose: Treatment
• Official Title: Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Aug 15, 2023
• Anticipated Study Completion Date: Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

2. Change in post-injection pain at 5 minutes using the Wong-Baker pain scale [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 pain scale.

3. Change in post-injection pain at 6 hours using the Short Form McGill Questionnaire Present Pain Intensity score. [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.

4. Change in post-injection pain at 6 hours using the Wong-Baker pain scale [Patients will be called for their rating 6 hours after injection]

   Patients will be asked to report their pain on the Wong-Baker pain scale.

5. Change in post-injection pain at 24 hours using the Short Form McGill Questionnaire Present Pain Intensity score. [Patients will be called for their rating 24 hours after injection]

   Patients will be asked to report their pain on the Short Form McGill Questionnaire Present Pain Intensity score.

6. Change in post-injection pain at 24 hours using the Wong-Baker pain scale [Patients will be called for their rating 24 hours after injection]

   Patients will be asked to report their pain on the Wong-Baker pain scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Consultants of Boston	Boston	Massachusetts	United States	02114
2	Mid Atlantic Retina	Bethlehem	Pennsylvania	United States	18017
3	Mid Atlantic Retina	Philadelphia	Pennsylvania	United States	19107
4	Retina Consultants of San Antonio	San Antonio	Texas	United States	78240
5	University of Toronto	Toronto	Ontario	Canada

Sponsors and Collaborators

• Wills Eye

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunir Garg MD, Retina Physician and Surgeon, Co-Director of Retina Research, Wills Eye
• ClinicalTrials.gov Identifier: NCT06130384
• Other Study ID Numbers: 012475
• First Posted: Nov 14, 2023
• Last Update Posted: Nov 14, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Pain; Bromfenac; Lubricant Eye Drops

Study Results

No Results Posted as of Nov 14, 2023