Trial Outcomes & Findings for Control of Pain in Intravitreal Injections Using Topical NSAIDs (NCT NCT04343222)
NCT ID: NCT04343222
Last Updated: 2023-06-12
Results Overview
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.
COMPLETED
PHASE4
46 participants
Baseline
2023-06-12
Participant Flow
Participants were patients with retinal disease requiring anti-VEGF therapy under the care of retinal specialists at the University of Wisconsin Hospital and Clinics.
Participant milestones
| Measure |
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
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.
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Control of Pain in Intravitreal Injections Using Topical NSAIDs
Baseline characteristics by cohort
| Measure |
Group A: Bromfenac Then Artificial Tears
n=16 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group B: Artificial Tears Then Bromfenac
n=15 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group C: Artificial Tears Then Artificial Tears
n=15 Participants
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.
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
77.69 years
STANDARD_DEVIATION 7.69 • n=99 Participants
|
78.67 years
STANDARD_DEVIATION 9.72 • n=107 Participants
|
73.40 years
STANDARD_DEVIATION 8.95 • n=206 Participants
|
76.61 years
STANDARD_DEVIATION 9.09 • n=7 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
15 participants
n=107 Participants
|
15 participants
n=206 Participants
|
46 participants
n=7 Participants
|
|
Mean Number of Prior Injections
|
20.81 injections
STANDARD_DEVIATION 17.40 • n=99 Participants
|
17.53 injections
STANDARD_DEVIATION 14.40 • n=107 Participants
|
10.80 injections
STANDARD_DEVIATION 12.81 • n=206 Participants
|
16.48 injections
STANDARD_DEVIATION 15.62 • n=7 Participants
|
|
Indication for Intravitreal Injection
Age-related macular degeneration
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Indication for Intravitreal Injection
Branch Retinal Vein Occlusion
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Indication for Intravitreal Injection
Diabetic Macular Edema
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Indication for Intravitreal Injection
Central retinal vein occlusion
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Indication for Intravitreal Injection
myopic degeneration
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
anti-VEGF agent used as SOC
bevacizumab
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
anti-VEGF agent used as SOC
aflibercept
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: BaselineAssessment 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.
Outcome measures
| Measure |
Group A: Bromfenac Then Artificial Tears
n=16 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group B: Artificial Tears Then Bromfenac
n=15 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group C: Artificial Tears Then Artificial Tears
n=15 Participants
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.
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
|---|---|---|---|
|
McGill Pain Questionnaire (SF-MPQ) Scores at Baseline
|
0.62 score on a scale
Interval 0.0 to 3.0
|
0.93 score on a scale
Interval 0.0 to 4.0
|
0.53 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: 6 hours post injectionAssessment 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.
Outcome measures
| Measure |
Group A: Bromfenac Then Artificial Tears
n=16 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group B: Artificial Tears Then Bromfenac
n=15 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group C: Artificial Tears Then Artificial Tears
n=15 Participants
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.
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
|---|---|---|---|
|
McGill Pain Questionnaire (SF-MPQ) Scores at 6 Hours Post Injection
|
0.50 score on a scale
Interval 0.0 to 2.0
|
0.13 score on a scale
Interval 0.0 to 1.0
|
0.13 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: 24 hours post injectionAssessment 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.
Outcome measures
| Measure |
Group A: Bromfenac Then Artificial Tears
n=16 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group B: Artificial Tears Then Bromfenac
n=15 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group C: Artificial Tears Then Artificial Tears
n=15 Participants
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.
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
|---|---|---|---|
|
McGill Pain Questionnaire (SF-MPQ) Scores at 24 Hours Post Injection
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: BaselineAssessment 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."
Outcome measures
| Measure |
Group A: Bromfenac Then Artificial Tears
n=16 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group B: Artificial Tears Then Bromfenac
n=15 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group C: Artificial Tears Then Artificial Tears
n=15 Participants
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.
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
|---|---|---|---|
|
Wong-Baker FACES Pain Scale Scores at Baseline
|
0.75 score on a scale
Interval 0.0 to 2.0
|
1.13 score on a scale
Interval 0.0 to 2.0
|
0.53 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: 6 hours post injectionAssessment 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."
Outcome measures
| Measure |
Group A: Bromfenac Then Artificial Tears
n=16 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group B: Artificial Tears Then Bromfenac
n=15 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group C: Artificial Tears Then Artificial Tears
n=15 Participants
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.
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
|---|---|---|---|
|
Wong-Baker FACES Pain Scale Scores at 6 Hours Post Injection
|
0.53 score on a scale
Interval 0.0 to 2.0
|
0.07 score on a scale
Interval 0.0 to 1.0
|
0.13 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: 24 hours post injectionAssessment 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."
Outcome measures
| Measure |
Group A: Bromfenac Then Artificial Tears
n=16 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group B: Artificial Tears Then Bromfenac
n=15 Participants
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.
Bromfenac: An NSAID used to treat eye pain and swelling
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
Group C: Artificial Tears Then Artificial Tears
n=15 Participants
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.
Artificial tears: eye drops to lubricate the eye and maintain moisture
|
|---|---|---|---|
|
Wong-Baker FACES Pain Scale Scores at 24 Hours Post Injection
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
Adverse Events
Group A: Bromfenac Then Artificial Tears
Group B: Artificial Tears Then Bromfenac
Group C: Artificial Tears Then Artificial Tears
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place