COPIVIN: Control of Pain in Intravitreal Injections Using Topical NSAIDs

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT04343222
Collaborator
(none)
46
Enrollment
1
Location
3
Arms
5.7
Actual Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Detailed Description

Intravitreal injections are a very common form of treatment for a variety of ocular pathologies. The use of these injections has only increased given the large utility they provide. They both improved visual outcomes and provided patients an overall better quality of life. However, a problem experienced by patients who undergo these injections is the need for multiple reoccurring injections to maintain control of their disease. It has long been an issue to provide patients optimal pain relief both during and after their intravitreal injections. Topical anesthesia is often utilized through frequent rounds of proparacaine eye drops. Other providers often use Lidocaine gel or Lidocaine-soaked cotton swaps with variable results in terms of pain control. Subconjunctival lidocaine has also been utilized with variable control of pain, however patients did report anxiety with the thought of being given an additional injection.

Patient pain is subjective and difficult to objectively quantify when comparing different methods of post-injection control. One commonly employed pain rating system is the Wong-Baker FACES pain scale which has been quite successful in objectively quantifying patient discomfort. It should be noted that this scale is only reliable in a patient whom is able to understand how the scale works.

Other research studies have shown adequate to improved pain control through the use of topical non-steroidal anti-inflammatory drug (NSAID) eye drops. One study looked at the use of topical Nepafenac 0.10% on post injection pain. This study used the McGill pain assessment questionnaire, which not only quantified pain but the additional benefit of describing the nature of the pain the patient experienced.

A clinical research study looked at pain immediately and 6 hours after injection. The researchers found that when compared to the control group (artificial tears) the group who received NSAID eye drops had better pain control. In a similar study, Bromfenac, another topical NSAID eye drop, provided good pain relief post injection, setting a precedent for the use of topical NSAIDs in controlling IVI pain.

However, studies have only reported pain relief immediately and 6 hours after injection. There have not been any studies showing pain control 24 hours post injection. Furthermore, no studies to date have compared the timing of application of a topical NSAID, in the alleviation of long-term pain patients experience. Bromfenac 0.09% is the agent of choice given its previously demonstrated effectiveness in pain control and also strength when compared to other ophthalmic NSAIDs. This was demonstrated in a paper by Sheppard that compared Bromfenac with other topical NSAID eye drops and proved that it offered approximately 3-4 times higher levels of COX-2 inhibition. It has been approved by the FDA as a one time daily eye drop to reduce inflammation. It is commonly utilized following cataract surgery to help reduce intraocular inflammation. This study looks at this medication's utility to control pain following IVI, another invasive procedure. Pain control would be assessed immediately following injection, 6 hours post injection and 24 hours post injection. This will allow evaluation of Bromfenac 0.09%'s effectiveness on overall immediate pain control as well as on ocular discomfort/soreness that can often follow IVI. Additionally, two intervention groups to compare Bromfenac 0.09% instillation 30 minutes prior to IVI and instillation immediately following IVI.

The primary goal of this study is to determine if topically administered Bromfenac 0.09% eye drops can reduce the discomfort that patient experience both during and after intravitreal injections. Additionally, the effect of both pre and post injection application of topical Bromfenac 0.09% on subjective pain scores will be investigated.

This study will be a pilot study consisting of 46 participants. These participants will be selected from those that have a diagnosis requiring intravitreal injection of an anti-VEGF agent (Vascular Endothelial Growth Factor (VEGF)). Participants that have already undergone intravitreal injection at least once before will be eligible. This will serve to minimize bias from initial injection anxiety and will give participants a comparative data point (prior injection discomfort). Participants will be randomized into one of three groups, which will be known as group A, B or C. The groups will have drop regimens as follows:

  • Group A: Will receive 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.

  • Group B: Will receive 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.

  • Group C: Will receive 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.

All labels will be removed from the bottles and the participants will be blinded to which group they belong to. The treating physicians will also be blinded to which group the participants belong to.

Immediately following the injection, each participant will be asked to rate their pain using the Wong-Baker FACES pain scale as well as the McGill Pain Questionnaire (SF-MPQ). Participants will then be given instructions and will be told to expect a call at 6 and 24 hours regarding further follow up phone questionnaires. Participants will also be provided with a phone number to contact should they have any complications (ie. discomfort, increased pain, vision changes, or any other questions). Participants will be provided with a copy of the Wong-Baker FACES pain scale and the McGill Pain Questionnaire to take home with them. Participants will be called 6 hours post-injection for further assessment of their pain using both the Wong-Baker FACES pain scale and the McGill Pain Questionnaire (SF-MPQ). At 24 hours, participants will again be contacted and their pain will be assessed one final time using both the Wong-Baker FACES pain scale and the McGill Pain Questionnaire (SF-MPQ). This will serve as the last point of data gathered from participants.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Control of Pain in Intravitreal Injections (COPIVIN Study): A Study Evaluating the Use of Combination Topical Anesthetic and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Actual Study Start Date :
Jun 27, 2019
Actual Primary Completion Date :
Dec 19, 2019
Actual Study Completion Date :
Dec 19, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group A: Bromfenac then Artificial Tears

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
An NSAID used to treat eye pain and swelling

Drug: Artificial tears
eye drops to lubricate the eye and maintain moisture

Experimental: Group B: Artificial Tears then Bromfenac

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
An NSAID used to treat eye pain and swelling

Drug: Artificial tears
eye drops to lubricate the eye and maintain moisture

Placebo Comparator: Group C: Artificial Tears then Artificial Tears

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
eye drops to lubricate the eye and maintain moisture

Outcome Measures

Primary Outcome Measures

  1. McGill Pain Questionnaire (SF-MPQ) Scores at Baseline [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.

  2. McGill Pain Questionnaire (SF-MPQ) Scores at 6 Hours Post Injection [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.

  3. McGill Pain Questionnaire (SF-MPQ) Scores at 24 Hours Post Injection [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.

  4. Wong-Baker FACES Pain Scale Scores at Baseline [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."

  5. Wong-Baker FACES Pain Scale Scores at 6 Hours Post Injection [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. Wong-Baker FACES Pain Scale Scores at 24 Hours Post Injection [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."

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Eyes with retinal pathology requiring anti-VEGF therapy

  • Previously had an IVI

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of WisconsinMadisonWisconsinUnited States53792

Sponsors and Collaborators

  • University of Wisconsin, Madison

Investigators

  • Principal Investigator: Mihai Mititelu, MD, MPH, University of Wisconsin, Madison
  • Principal Investigator: Maxwell Wingelaar, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT04343222
Other Study ID Numbers:
  • 2019-0095
  • A536000
  • SMPH/OPHTHAL&VIS SCI/GEN
First Posted:
Apr 13, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Wisconsin, Madison
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsParticipants were patients with retinal disease requiring anti-VEGF therapy under the care of retinal specialists at the University of Wisconsin Hospital and Clinics.
Pre-assignment Detail
Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moisture
Period Title: Overall Study
STARTED161515
COMPLETED161515
NOT COMPLETED000

Baseline Characteristics

Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial TearsTotal
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moistureTotal of all reporting groups
Overall Participants16151546
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
77.69
(7.69)
78.67
(9.72)
73.40
(8.95)
76.61
(9.09)
Sex: Female, Male (Count of Participants)
Female
13
81.3%
5
33.3%
13
86.7%
31
67.4%
Male
3
18.8%
10
66.7%
2
13.3%
15
32.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
0
0%
Not Hispanic or Latino
16
100%
15
100%
15
100%
46
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
0
0%
White
16
100%
15
100%
15
100%
46
100%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
16
100%
15
100%
15
100%
46
100%
Mean Number of Prior Injections (injections) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [injections]
20.81
(17.40)
17.53
(14.40)
10.80
(12.81)
16.48
(15.62)
Indication for Intravitreal Injection (Count of Participants)
Age-related macular degeneration
14
87.5%
12
80%
9
60%
35
76.1%
Branch Retinal Vein Occlusion
2
12.5%
2
13.3%
2
13.3%
6
13%
Diabetic Macular Edema
0
0%
0
0%
3
20%
3
6.5%
Central retinal vein occlusion
0
0%
1
6.7%
0
0%
1
2.2%
myopic degeneration
0
0%
0
0%
1
6.7%
1
2.2%
anti-VEGF agent used as SOC (Count of Participants)
bevacizumab
8
50%
8
53.3%
9
60%
25
54.3%
aflibercept
8
50%
7
46.7%
6
40%
21
45.7%

Outcome Measures

1. Primary Outcome
TitleMcGill Pain Questionnaire (SF-MPQ) Scores at Baseline
DescriptionAssessment 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.
Time FrameBaseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moisture
Measure Participants161515
Mean (Full Range) [score on a scale]
0.62
0.93
0.53
2. Primary Outcome
TitleMcGill Pain Questionnaire (SF-MPQ) Scores at 6 Hours Post Injection
DescriptionAssessment 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.
Time Frame6 hours post injection

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moisture
Measure Participants161515
Mean (Full Range) [score on a scale]
0.50
0.13
0.13
3. Primary Outcome
TitleMcGill Pain Questionnaire (SF-MPQ) Scores at 24 Hours Post Injection
DescriptionAssessment 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.
Time Frame24 hours post injection

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moisture
Measure Participants161515
Mean (Full Range) [score on a scale]
0
0
0
4. Primary Outcome
TitleWong-Baker FACES Pain Scale Scores at Baseline
DescriptionAssessment 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."
Time FrameBaseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moisture
Measure Participants161515
Mean (Full Range) [score on a scale]
0.75
1.13
0.53
5. Primary Outcome
TitleWong-Baker FACES Pain Scale Scores at 6 Hours Post Injection
DescriptionAssessment 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."
Time Frame6 hours post injection

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moisture
Measure Participants161515
Mean (Full Range) [score on a scale]
0.53
0.07
0.13
6. Primary Outcome
TitleWong-Baker FACES Pain Scale Scores at 24 Hours Post Injection
DescriptionAssessment 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."
Time Frame24 hours post injection

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moisture
Measure Participants161515
Mean (Full Range) [score on a scale]
0
0
0

Adverse Events

Time FrameParticipants will have the opportunity to report adverse events at the time of the procedure and at 6 hours and 24 hours post injection.
Adverse Event Reporting Description
Arm/Group TitleGroup A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Arm/Group DescriptionParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipant 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. Bromfenac: An NSAID used to treat eye pain and swelling Artificial tears: eye drops to lubricate the eye and maintain moistureParticipants 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. Artificial tears: eye drops to lubricate the eye and maintain moisture
All Cause Mortality
Group A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/16 (0%) 0/15 (0%) 0/15 (0%)
Serious Adverse Events
Group A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/16 (0%) 0/15 (0%) 0/15 (0%)
Other (Not Including Serious) Adverse Events
Group A: Bromfenac Then Artificial TearsGroup B: Artificial Tears Then BromfenacGroup C: Artificial Tears Then Artificial Tears
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/16 (0%) 0/15 (0%) 0/15 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleMaxwell Wingelaar
OrganizationUniversity of Wisconsin - Madison
Phone231-233-6051
Emailmwingelaar@uwhealth.org
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT04343222
Other Study ID Numbers:
  • 2019-0095
  • A536000
  • SMPH/OPHTHAL&VIS SCI/GEN
First Posted:
Apr 13, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Sep 1, 2020