A Phase 4 interventional study of Bromfenac and Nepafenac in Inflammation and Pseudophakia, sponsored by Toyos Clinic. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by Toyos Clinic · Phase 4, Interventional, and Treatment
This is a single-center, randomized, investigator-masked, parallel group, and active-comparator controlled study investigating the clinical outcomes for visual acuity and macular thickness after treatment with Bromday (bromfenac ophthalmic solution) 0.09% QD or Nevanac (nepafenac ophthalmic suspension) 0.1% TID in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.
Two topical NSAIDs currently approved for postoperative treatment of pain and inflammation in cataract surgery are bromfenac 0.09% and nepafenac 0.1%. Both purport to treat ocular inflammation by acting as a potent inhibitor of COX-1 and COX-2 enzymes. Clinical studies to date lack clarity on which topical NSAID may be the most efficacious.
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's enrollment of 23 is below the median of 45 across 25 interventional studies indexed under Pseudophakia.
Browse Pseudophakia studies →Toyos Clinic is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Compared within Pseudophakia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving Bromday self-administered one drop of bromfenac 0.09% daily as a topical ophthalmic drop three days prior to cataract surgery, on the day of cataract surgery and 21 days post operatively.
Drug: Bromfenac
Patients in this arm self-administered nepafenac topical ophthalmic drops three times daily beginning 3 days prior to cataract surgery, on the day of surgery and for 21 days postoperatively in addition to usual cataract procedure.
Drug: Nepafenac
bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
Also known as: Bromday (bromfenac ophthalmic solution) 0.9%
nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
Also known as: Nevanac (nepafenac ophthamic suspension) 0.1%
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities
ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.
Time frame: Week 6
Summed Ocular Inflammation Score (SOIS)
An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4\>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(\>30 cell/high powered field +3 (severe flare).
Time frame: Week 6
OCT Retinal Thickness
Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.
Time frame: Week 6
Macular Volume
Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength
Time frame: 6 weeks
Clinical outcomes of bromfenac ophthalmic solution 0.09% QD and nepafenac 0.1% ophthalmic suspension TID post cataract surgery with posterior chamber intraocular lens implantation, specifically looking at any differences in Early Treatment Diabetic Retinopathy Study visual acuities, macular volume, and/or retinal thickness changes.
| Milestone | Bromday | Nevanac |
|---|---|---|
| Started | 12 | 11 |
| Completed | 10 | 10 |
| Not completed | 2 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Advanced psc cataract outlier | 1 | 0 |
ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.
| letters | Bromday | Nevanac |
|---|---|---|
| Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities | 51.3 ± 6.818 | 52 ± 6.750 |
An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4\>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(\>30 cell/high powered field +3 (severe flare).
| units on a scale | Bromday | Nevanac |
|---|---|---|
| Summed Ocular Inflammation Score (SOIS) | 0.15 ± 0.229 | 0.2 ± 0.245 |
Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.
| micrometers cubed | Bromday | Nevanac |
|---|---|---|
| OCT Retinal Thickness | 230.7 ± 30.63 | 223.8 ± 25.36 |
Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength
| mm cubed | Bromday | Nevanac |
|---|---|---|
| Macular Volume | 0.1815 ± 0.49 | 0.1765 ± 0.34 |
Non-serious events are listed at a 0.05% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bromday | — | 0/12 (0%) | 0/12 (0%) |
| Nevanac | — | 0/11 (0%) | 1/11 (9.1%) |
| Event | Bromday | Nevanac |
|---|---|---|
| recurrent symptomatic postoperative iritisEye disorders | 0/12 | 1/11 |
1 nepafenac patient did not use test article prior to surgery. 1 bromday patient used nsaid during study. 1 bromday patient had advanced psc cataract.
| Age, Categorical(Participants) | Bromday | Nevanac | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 10 | 21 |
| >=65 years | 1 | 1 | 2 |
| Age, Continuous(years) | Bromday | Nevanac | Total |
|---|---|---|---|
| Mean | 70.1 ± 10.5 | 69.7 ± 9.0 | 69.9 ± 9.5 |
| Sex: Female, Male(Participants) | Bromday | Nevanac | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 7 | 5 | 12 |
| Region of Enrollment(participants) | Bromday | Nevanac | Total |
|---|---|---|---|
| United States | 12 | 11 | 23 |
No study locations are listed for this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bromfenac
Toyos Clinic