Vein OcclusionPhase 4NCT07090044
Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period
A Phase 4 study testing Bromfenac Sodium 0.07%, Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly and Propylene Glycol Preservative-free Artificial Tears in people with Vein Occlusion and Macular Degeneration Choroidal Neovascularization, run by Retina Research Institute, LLC at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how various topical drops (bromfenac, loteprednol, and artificial tears) fare in alleviating post-intravitreal injection pain. The main questions it aims to answer are: Do bromfenac sodium and/or loteprednol etabonate improve post-injection pain scores compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vein Occlusion, Macular Degeneration Choroidal Neovascularization, Macular Edema
- What is being tested?
- Bromfenac Sodium 0.07%, Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly and Propylene Glycol Preservative-free Artificial Tears
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2021to 8 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Standard of Care Treatment with intravitreal injection
- History of at least 1 anti-VEGF injection in the 90 days prior to inclusion
- Less than 13 intravitreal injection in the 365 days prior to inclusion
Who cannot join
- History of autoimmune disease, graft versus host disease, neurotrophic corneal disease, contact lens use, keratitis, fibromyalgia, uveitis, herpetic ocular disease
- Drug allergy to any drug components
- History of any ocular surgery in the 30 days prior to inclusion
- Current topical corticosteroid or non-steroidal anti-inflammatory drug (NSAID)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn how various topical drops (bromfenac, loteprednol, and artificial tears) fare in alleviating post-intravitreal injection pain. The main questions it aims to answer are:
- Do bromfenac sodium and/or loteprednol etabonate improve post-injection pain scores compared to preservative-free artificial tears?
Read more
Participants will:
- Receive one drop of the topical drops five minutes prior to their regularly scheduled intravitreal injection. Depending on the treatment arm, they will also administer drops on their own at home up to 3 times per day on the day of their procedure.
- They will answer a standardized pain score survey at 4 hours and 24 hours following their intravitreal injection and convey their results to study coordinators by phone.
- Conditions
- Vein Occlusion, Macular Degeneration Choroidal Neovascularization, Macular Edema, Diabetic Retinopathy
- Being tested
- Bromfenac Sodium 0.07%, Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly, Propylene Glycol Preservative-free Artificial Tears
- Keywords
- Intravitreal Injection, Post-procedure Pain
- Medical subject headings
- Choroidal Neovascularization, Macular Edema, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac Sodium 0.07%Drug
Bromfenac sodium 0.07% is a nonsteroidal anti-inflammatory drug to be administered as one topical drop, one time 5 minutes prior to the regularly scheduled standard of care intravitreal injection.
Loteprednol Etabonate 0.38% Ophthalmic Gel/JellyDrug
Loteprednol etabonate 0.38% ophthalmic gel is a steroidal drug to be administered as one topical drop three times daily on the day of the regularly scheduled standard of care intravitreal injection. The first drop administered 5 minutes prior to the intravitreal injection.
Propylene Glycol Preservative-free Artificial TearsDrug
Propylene Glycol Preservative-free Artificial Tears is a placebo compartor administered as one topical drop three times daily on the day of the regularly scheduled standard of care intravitreal injection. The first drop administered 5 minutes prior to the intravitreal injection.
| Study group | Role | What they receive |
|---|---|---|
| Bromfenac | Active comparator | Bromfenac sodium 0.07% is a nonsteroidal anti-inflammatory drug to be administered as a topical drop in the eye receiving the standard of care intravitreal injection. Receives: Drug: Bromfenac Sodium 0.07% |
| Loteprednol | Active comparator | Loteprednol etabonate ophthalmic gel 0.38% is a steroidal drug to be administered as a topical drop in the eye receiving the standard of care intravitreal injection. Receives: Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly |
| Artificial Tears | Placebo comparator | Propylene Glycol Preservative-free artificial tears is a placebo comparator to be adminstered in the eye receiving the standard of care intravitreal injection. Receives: Drug: Propylene Glycol Preservative-free Artificial Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Pain Score
A standardized Visual Analog Scale (VAS) pain score is collected at 4 hours and 24 hours following standard of care intravitreal injection. Patients are provided a VAS scale and receive a call from study coordinators to collect pain scores.
Measured: At 4 hours and 24 hours following intravitreal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start20 Aug 2021
- Primary completion7 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vein OcclusionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Research Institute, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Sabin Dang, MD, Principal investigator, Retina Research Institute, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090044
- Sponsor's protocol ID
- 19928
- Status last verified
- May 2025
- First submitted
- 22 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD Collected throughout the trial
Publications
SakallioGlu AK, Kaya S, GarIp R, Guclu H. COMPARISON OF THE EFFECTS OF EIGHT DIFFERENT TOPICAL NONSTEROIDAL ANTI-INFLAMMATORY DRUGS ON REDUCING INTRAVITREAL INJECTION-INDUCED PAIN. Retina. 2024 Jul 1;44(7):1196-1202. doi: 10.1097/IAE.0000000000004085.
PubMed 38437826Lee DH, Kim M, Choi EY, Chin HS, Kim M. Efficacy of Pretreatment with Preservative-Free Topical Bromfenac in Improving Post-Intravitreal-Injection Pain: A Prospective Pilot Study. J Clin Med. 2022 Jul 18;11(14):4172. doi: 10.3390/jcm11144172.
PubMed 35887936Rifkin L, Schaal S. Shortening ocular pain duration following intravitreal injections. Eur J Ophthalmol. 2012 Nov-Dec;22(6):1008-12. doi: 10.5301/ejo.5000147. Epub 2012 Apr 24.
PubMed 22562296Shtayer C, Lily Okrent Smolar A, Elmalak M, Abayev L, Grzybowski A, Moisseiev E. Post-Intravitreal injection pain reduction using topical NSAIDS: A comparative study. Eur J Ophthalmol. 2025 Sep;35(5):1703-1709. doi: 10.1177/11206721231201176. Epub 2023 Sep 10.
PubMed 37691285Georgakopoulos CD, Tsapardoni F, Makri OE. EFFECT OF BROMFENAC ON PAIN RELATED TO INTRAVITREAL INJECTIONS: A Randomized Crossover Study. Retina. 2017 Feb;37(2):388-395. doi: 10.1097/IAE.0000000000001137.
PubMed 27442130Popovic MM, Muni RH, Nichani P, Kertes PJ. Topical Nonsteroidal Anti-inflammatory Drugs for Pain Resulting from Intravitreal Injections: A Meta-Analysis. Ophthalmol Retina. 2020 May;4(5):461-470. doi: 10.1016/j.oret.2020.01.024. Epub 2020 Feb 13.
PubMed 32199867
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period
- ClinicalTrials.gov ID
- NCT07090044
- Acronym / sponsor ID
- 19928
- Conditions
- Vein Occlusion, Macular Degeneration Choroidal Neovascularization, Macular Edema, Diabetic Retinopathy
- Keywords
- Intravitreal Injection, Post-procedure Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Retina Research Institute, LLCUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 29 Jul 2025 (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 goal of this clinical trial is to learn how various topical drops (bromfenac, loteprednol, and artificial tears) fare in alleviating post-intravitreal injection pain. The main questions it aims to answer are:
- Do bromfenac sodium and/or loteprednol etabonate improve post-injection pain scores compared to preservative-free artificial tears?
Participants will:
- Receive one drop of the topical drops five minutes prior to their regularly scheduled intravitreal injection. Depending on the treatment arm, they will also administer drops on their own at home up to 3 times per day on the day of their procedure.
- They will answer a standardized pain score survey at 4 hours and 24 hours following their intravitreal injection and convey their results to study coordinators by phone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bromfenac | Active comparator | Drug: Bromfenac Sodium 0.07%Bromfenac sodium 0.07% is a nonsteroidal anti-inflammatory drug to be administered as a topical drop in the eye receiving the standard of care intravitreal injection. |
| Loteprednol | Active comparator | Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/JellyLoteprednol etabonate ophthalmic gel 0.38% is a steroidal drug to be administered as a topical drop in the eye receiving the standard of care intravitreal injection. |
| Artificial Tears | Placebo comparator | Drug: Propylene Glycol Preservative-free Artificial TearsPropylene Glycol Preservative-free artificial tears is a placebo comparator to be adminstered in the eye receiving the standard of care intravitreal injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Standard of Care Treatment with intravitreal injection
- History of at least 1 anti-VEGF injection in the 90 days prior to inclusion
- Less than 13 intravitreal injection in the 365 days prior to inclusion
Key exclusion criteria (4 listed)
- History of autoimmune disease, graft versus host disease, neurotrophic corneal disease, contact lens use, keratitis, fibromyalgia, uveitis, herpetic ocular disease
- Drug allergy to any drug components
- History of any ocular surgery in the 30 days prior to inclusion
- Current topical corticosteroid or non-steroidal anti-inflammatory drug (NSAID)
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 |
|---|---|---|
| Bromfenac Sodium 0.07%Bromfenac sodium 0.07% is a nonsteroidal anti-inflammatory drug to be administered as one topical drop, one time 5 minutes prior to the regularly scheduled standard of care intravitreal injection. | Drug | Bromfenac |
| Loteprednol Etabonate 0.38% Ophthalmic Gel/JellyLoteprednol etabonate 0.38% ophthalmic gel is a steroidal drug to be administered as one topical drop three times daily on the day of the regularly scheduled standard of care intravitreal injection. The first drop administered 5 minutes prior to the intravitreal injection. | Drug | Loteprednol |
| Propylene Glycol Preservative-free Artificial TearsPropylene Glycol Preservative-free Artificial Tears is a placebo compartor administered as one topical drop three times daily on the day of the regularly scheduled standard of care intravitreal injection. The first drop administered 5 minutes prior to the intravitreal injection. | Drug | Artificial Tears |
Primary outcome
Visual Analog Scale Pain Score
Time frame: At 4 hours and 24 hours following intravitreal injection
A standardized Visual Analog Scale (VAS) pain score is collected at 4 hours and 24 hours following standard of care intravitreal injection. Patients are provided a VAS scale and receive a call from study coordinators to collect pain scores.
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 29 Jul 2025.
- Results publication: PubMed 38437826SakallioGlu AK, Kaya S, GarIp R, Guclu H. COMPARISON OF THE EFFECTS OF EIGHT DIFFERENT TOPICAL NONSTEROIDAL ANTI-INFLAMMATORY DRUGS ON REDUCING INTRAVITREAL INJECTION-INDUCED PAIN. Retina. 2024 Jul 1;44(7):1196-1202. doi: 10.1097/IAE.0000000000004085.
- Results publication: PubMed 35887936Lee DH, Kim M, Choi EY, Chin HS, Kim M. Efficacy of Pretreatment with Preservative-Free Topical Bromfenac in Improving Post-Intravitreal-Injection Pain: A Prospective Pilot Study. J Clin Med. 2022 Jul 18;11(14):4172. doi: 10.3390/jcm11144172.
- Results publication: PubMed 22562296Rifkin L, Schaal S. Shortening ocular pain duration following intravitreal injections. Eur J Ophthalmol. 2012 Nov-Dec;22(6):1008-12. doi: 10.5301/ejo.5000147. Epub 2012 Apr 24.
- Results publication: PubMed 37691285Shtayer C, Lily Okrent Smolar A, Elmalak M, Abayev L, Grzybowski A, Moisseiev E. Post-Intravitreal injection pain reduction using topical NSAIDS: A comparative study. Eur J Ophthalmol. 2025 Sep;35(5):1703-1709. doi: 10.1177/11206721231201176. Epub 2023 Sep 10.
- Results publication: PubMed 27442130Georgakopoulos CD, Tsapardoni F, Makri OE. EFFECT OF BROMFENAC ON PAIN RELATED TO INTRAVITREAL INJECTIONS: A Randomized Crossover Study. Retina. 2017 Feb;37(2):388-395. doi: 10.1097/IAE.0000000000001137.
- Results publication: PubMed 32199867Popovic MM, Muni RH, Nichani P, Kertes PJ. Topical Nonsteroidal Anti-inflammatory Drugs for Pain Resulting from Intravitreal Injections: A Meta-Analysis. Ophthalmol Retina. 2020 May;4(5):461-470. doi: 10.1016/j.oret.2020.01.024. Epub 2020 Feb 13.
- Individual participant dataSharing planned: Yes. All IPD Collected throughout the trial
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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.
Sabin Dang, MD principal investigator
Retina Research Institute, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bromfenac Sodium 0.07%, Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly and Propylene Glycol Preservative-free Artificial Tears in people with Vein Occlusion and Macular Degeneration Choroidal Neovascularization, run by Retina Research Institute, LLC at 1 site in United States.
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 3 inclusion and 4 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Visual Analog Scale Pain Score (time frame: At 4 hours and 24 hours following intravitreal injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07090044, which also lists 6 linked publications.
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 29 Jul 2025.