PainPhase 4NCT06130384
Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
A Phase 4 study testing Use of bromfenac 0.09% to reduce intravitreal injection pain and Use of artificial tears to reduce intravitreal injection pain in people with Pain and Intravitreal Injection, run by Wills Eye at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Intravitreal Injection, Pain, Acute
- What is being tested?
- Use of bromfenac 0.09% to reduce intravitreal injection pain and Use of artificial tears to reduce intravitreal injection pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Mar 2021to 15 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Mid Atlantic Retina
Bethlehem, Pennsylvania, 18017
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Retina Consultants of San Antonio
San Antonio, Texas, 78240
About this study
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.
Read the 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.
- Conditions
- Pain, Intravitreal Injection, Pain, Acute
- Being tested
- Use of bromfenac 0.09% to reduce intravitreal injection pain, Use of artificial tears to reduce intravitreal injection pain
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of bromfenac 0.09% to reduce intravitreal injection painDrug
The eyedrop (bromfenac) will be given to the assigned eye.
Use of artificial tears to reduce intravitreal injection painDrug
The eyedrop (artificial tears) will be given to the assigned eye.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Use of artificial tears to reduce intravitreal injection pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Patients will be called for their rating 24 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Mar 2021
- Primary completion15 Aug 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunir Garg MD, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130384
- Sponsor's protocol ID
- 012475
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified data will be shared amongst researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
- ClinicalTrials.gov ID
- NCT06130384
- Acronym / sponsor ID
- 012475
- Conditions
- Pain, Intravitreal Injection, Pain, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bromfenac 0.09% | Experimental | Drug: Use of bromfenac 0.09% to reduce intravitreal injection painAt 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. |
| Artificial Tear | Placebo comparator | Drug: Use of artificial tears to reduce intravitreal injection painAt 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Prior ocular surgery (non-cataract)
- Herpetic eye disease
- Uncontrolled uveitis
- Active conjunctivitis, keratitis or keratopathy
- Current unilateral use of prescription eye drops.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of bromfenac 0.09% to reduce intravitreal injection painThe eyedrop (bromfenac) will be given to the assigned eye. | Drug | Bromfenac 0.09% |
| Use of artificial tears to reduce intravitreal injection painThe eyedrop (artificial tears) will be given to the assigned eye. | Drug | Artificial Tear |
Primary outcome
Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score
Time frame: 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, ranging from 0 to 5, in which 5 is the worst pain level.
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
Time frame: 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 Faces pain scale, ranging from 0 through 10, in which 10 is the worst pain level.
Change in post-injection pain at 6 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
Time frame: 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, ranging from 0 to 5, in which 5 is the worst pain level.
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
Time frame: Patients will be called for their rating 6 hours after injection
from 0 through 10, in which 10 is the worst pain level.
Change in post-injection pain at 24 hours using the Short Form McGill Pain Questionnaire Present Pain Intensity score.
Time frame: Patients will be called for their rating 24 hours after injection
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.
Change in post-injection pain at 5 minutes using the Wong-Baker Faces pain scale
Time frame: Patients will be called for their rating 24 hours after injection
from 0 through 10, in which 10 is the worst pain level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: Yes. Only de-identified data will be shared amongst researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Use of bromfenac 0.09% to reduce intravitreal injection pain and Use of artificial tears to reduce intravitreal injection pain in people with Pain and Intravitreal Injection, run by Wills Eye at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-injection pain at 5 minutes using the Short Form McGill Pain Questionnaire Present Pain Intensity score (time frame: Patients will be asked in the office for their pain rating 5 minutes after injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.