Control of Pain in Intravitreal Injections Using Topical NSAIDs

NCT04343222 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: 2019-0095A536000SMPH/OPHTHAL&VIS SCI/GEN
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Intravitreal injections (IVI) are a common form of treatment for multiple retinal pathologies. The investigators hypothesize that an intervention with a topical NSAID will alleviate pain experienced at intravitreal injection (IVI) and post-IVI. 46 participants will be recruited, randomized into 1 of 3 treatment arms, and can expect to be on study for a day.

Conditions

Intravitreal Injections; IVI

Keywords

pain

Outcome Measures

Primary Outcomes (6)

• McGill Pain Questionnaire (SF-MPQ) Scores at Baseline

  Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in participants undergoing intravitreal injections (IVI) of anti-VEGFs as measured by the SF-MPQ. The SF-MPQ questionnaire contains 15 sensory and affective descriptors each rated on a 0-3 scale where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. The total possible range of scores is 0-45 where the higher the score, the more intense the pain.

  Baseline

• McGill Pain Questionnaire (SF-MPQ) Scores at 6 Hours Post Injection

  Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in participants undergoing intravitreal injections (IVI) of anti-VEGFs as measured by the SF-MPQ. The SF-MPQ questionnaire contains 15 sensory and affective descriptors each rated on a 0-3 scale where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. The total possible range of scores is 0-45 where the higher the score, the more intense the pain.

  6 hours post injection

• McGill Pain Questionnaire (SF-MPQ) Scores at 24 Hours Post Injection

  Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in participants undergoing intravitreal injections (IVI) of anti-VEGFs as measured by the SF-MPQ. The SF-MPQ questionnaire contains 15 sensory and affective descriptors each rated on a 0-3 scale where 0 is none, 1 is mild, 2 is moderate, and 3 is severe. The total possible range of scores is 0-45 where the higher the score, the more intense the pain.

  24 hours post injection

• Wong-Baker FACES Pain Scale Scores at Baseline

  Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in patients undergoing intravitreal injections of anti-VEGFs as measured by the Wong-Baker FACES pain scale. This scale is compromised of drawings of faces that appear to be experiencing increasing pain, from which the participant chooses their current level of pain. Scoring is defined on the scale as, "Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain."

  Baseline

• Wong-Baker FACES Pain Scale Scores at 6 Hours Post Injection

  Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in patients undergoing intravitreal injections of anti-VEGFs as measured by the Wong-Baker FACES pain scale. This scale is compromised of drawings of faces that appear to be experiencing increasing pain, from which the participant chooses their current level of pain. Scoring is defined on the scale as, "Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain."

  6 hours post injection

• Wong-Baker FACES Pain Scale Scores at 24 Hours Post Injection

  Assessment of topical 0.09% Bromfenac's analgesic effect pre- and post-injection in patients undergoing intravitreal injections of anti-VEGFs as measured by the Wong-Baker FACES pain scale. This scale is compromised of drawings of faces that appear to be experiencing increasing pain, from which the participant chooses their current level of pain. Scoring is defined on the scale as, "Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain."

  24 hours post injection

Study Arms (3)

Group A: Bromfenac then Artificial Tears

EXPERIMENTAL

Participant receives 1 drop of topical Bromfenac 0.09% 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.

Drug: Bromfenac; Drug: Artificial tears

Group B: Artificial Tears then Bromfenac

EXPERIMENTAL

Participant receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of topical Bromfenac 0.09% immediately after the injection and wash.

Drug: Bromfenac; Drug: Artificial tears

Group C: Artificial Tears then Artificial Tears

PLACEBO COMPARATOR

Participants receives 1 drop of an artificial tear eye drop 30 minutes prior to the injection and then 1 drop of an artificial tear eye drop immediately after the injection and wash.

Drug: Artificial tears

Interventions

Bromfenac DRUG

An NSAID used to treat eye pain and swelling

Group A: Bromfenac then Artificial Tears; Group B: Artificial Tears then Bromfenac

Artificial tears DRUG

eye drops to lubricate the eye and maintain moisture

Group A: Bromfenac then Artificial Tears; Group B: Artificial Tears then Bromfenac; Group C: Artificial Tears then Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eyes with retinal pathology requiring anti-VEGF therapy
• Previously had an IVI

You may not qualify if:

• History of previous eye surgery other than cataract extraction
• Herpetic eye disease
• Uncontrolled glaucoma
• Uveitis
• Acute conjunctivitis
• Pregnancy
• Known previous adverse response or contraindication to intravitreal injection, Bromfenac, or other NSAIDs.
• Keratitis including povidone-induced keratitis
• Bullous keratopathy
• Diagnosis of dry eye syndrome
• Uncontrolled diabetes
• NSAID use 3 days prior to IVI

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Pain

Interventions

bromfenac; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Limitations and Caveats

The sample size was originally powered for a difference of 1.0 on the FACES scale. Due to the clustering of results and low pain scores reported in all arms, the 95% confidence interval included zero and prevented statistical analysis.

Results Point of Contact

• Title: Maxwell Wingelaar
• Organization: University of Wisconsin - Madison

mwingelaar@uwhealth.org

231-233-6051

Study Officials

• Mihai Mititelu, MD, MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Maxwell Wingelaar, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: June 27, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: June 12, 2023
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)