Cataract, Inflammation, Retinal Edema
Conditions
Keywords
Retinal edema, Cataract, inflammation
Brief summary
To investigate inflammation, visual acuity and macular thickness after treatment with Prolensa vs Ilevro after cataract surgery.
Detailed description
To investigate the clinical outcomes for inflammation, visual acuity and macular thickness after treatment with Prolensa (bromfenac ophthalmic solution) 0.07% QD in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.
Interventions
DRUGProlensa (bromfenac 0.07%)
Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery
DRUGIlevro (nepafenac 0.3%)
Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery
Sponsors
Bausch & Lomb Incorporated
Melissa Toyos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are male or female at least 18 years of age who require cataract surgery and no other surgical procedures during the cataract surgery. * Agree not to have any other ocular surgical procedures in the study or fellow (non study) eye within 15 days prior to the initiation of dosing with the test article or throughout the duration of the study. * Have a Best Corrected Visual Acuity of 20/200 or better in either eye. * Are able to self administer test article (or have a caregiver available to instill all doses of test article).
Exclusion criteria
* Have known hypersensitivity to bromfenac, nepafenac, loteprednol or any component of the test article (including procedural medications such as anesthetic and/or fluorescein drops, dilating drops, etc.). * Have a known hypersensitivity to salicylates (i.e., aspirin) or NSAIDs (nonsteroidal antiinflammatory drug). * Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in study eye at screening visit. * Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease. * Have used ocular, topical, or systemic NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 7 days prior to initiation of dosing with the test article or throughout the duration of study,with exception of allowing patients on a stable dose of aspirin 81 mg daily or less. * Have used ocular prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study. * Have active corneal pathology noted in the study eye at screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. Superficial punctate keratitis in study eye. * Have any extraocular/intraocular inflammation in the study eye at screening visit (blepharitis allowed if mild only, and no concurrent conjunctivitis or lid erythema/edema) or ongoing, unresolved uveitis. * Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening. * Have had radial keratotomy, corneal transplant, or corneal refractive surgery in the study eye within the last two years. * Have a history of abuse of alcohol/drugs within six months prior to the screening visit. * Are pregnant or nursing/lactating. * Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment of Inflammation Associated With Cataract Surgery | change from baseline to final at post op 42 days +/-7 days | Units on a scale. Biomicroscopy with slit lamp beam of 0.3 mm in width and 1.0 mm in height will be used to determine anterior cell and flare scores at each study visit by counting each individual white blood cell present and grading the flare (measure of protein and marker of inflammation in aqueous fluid). The sum of the severity of cell count and the flare grade will be called the Summed Ocular Inflammation Score (SOIS) and measured at each time point. The scale is 0-4 range for both values cells counted and flare where 0=no cell and 0=complete abscence of flare; 0.5 = 1-5 cells (trace) and 0= no flare; 1=6-15 cells and 1=very slight (barely detectable ) flare, 2=16-25 cells and 2=moderate flare (iris and lens clear), 3=26-30 cells and 3 =marked (iris and lens hazy) and 4=\> |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | baseline score to final postoperative visit at 42 days +/-7 days | ETDRS log MAR Visual Acuity from baseline to final postoperative visit. The change was calculated as the difference of the value at the later time point minus the value at the earlier time point. The scale runs from -0.30 (corresponding to 20/10) or better visual acuity to 1(20/200) or worse visual acuity with the smaller or more negative numbers indicating better visual acuity outcomes and larger numbers indicating worsened visual acuity outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Retinal Thickness | change from baseline to final postoperative visit at 42 days +/- 7 days | Change in Retinal Thickness from baseline to final postoperative visit as measured by an SD-OCT |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prolensa (Bromfenac 0.07%) Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.
Prolensa (bromfenac 0.07%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery | 25 |
| Ilevro (Nepafenac 0.3%) Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.
Ilevro (nepafenac 0.3%): Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Prolensa (Bromfenac 0.07%) | Ilevro (Nepafenac 0.3%) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 5 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 20 Participants | 32 Participants |
| Age, Continuous | 68.3 years | 66.9 years | 67.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 24 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 7 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 18 Participants | 35 Participants |
| Region of Enrollment United States | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 1 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Treatment of Inflammation Associated With Cataract Surgery
Units on a scale. Biomicroscopy with slit lamp beam of 0.3 mm in width and 1.0 mm in height will be used to determine anterior cell and flare scores at each study visit by counting each individual white blood cell present and grading the flare (measure of protein and marker of inflammation in aqueous fluid). The sum of the severity of cell count and the flare grade will be called the Summed Ocular Inflammation Score (SOIS) and measured at each time point. The scale is 0-4 range for both values cells counted and flare where 0=no cell and 0=complete abscence of flare; 0.5 = 1-5 cells (trace) and 0= no flare; 1=6-15 cells and 1=very slight (barely detectable ) flare, 2=16-25 cells and 2=moderate flare (iris and lens clear), 3=26-30 cells and 3 =marked (iris and lens hazy) and 4=\>
Time frame: change from baseline to final at post op 42 days +/-7 days
Population: patients undergoing uncomplicated cataract surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolensa (Bromfenac 0.07%) | Treatment of Inflammation Associated With Cataract Surgery | 0.01 units on a scale | Standard Deviation 0.3 |
| Ilevro (Nepafenac 0.3%) | Treatment of Inflammation Associated With Cataract Surgery | 0.01 units on a scale | Standard Deviation 0.4 |
Secondary
Visual Acuity
ETDRS log MAR Visual Acuity from baseline to final postoperative visit. The change was calculated as the difference of the value at the later time point minus the value at the earlier time point. The scale runs from -0.30 (corresponding to 20/10) or better visual acuity to 1(20/200) or worse visual acuity with the smaller or more negative numbers indicating better visual acuity outcomes and larger numbers indicating worsened visual acuity outcomes.
Time frame: baseline score to final postoperative visit at 42 days +/-7 days
Population: patients undergoing uncomplicated cataract surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolensa (Bromfenac 0.07%) | Visual Acuity | .19 logMar | Standard Deviation 0.2 |
| Ilevro (Nepafenac 0.3%) | Visual Acuity | .21 logMar | Standard Deviation 0.25 |
Other Pre-specified
Retinal Thickness
Change in Retinal Thickness from baseline to final postoperative visit as measured by an SD-OCT
Time frame: change from baseline to final postoperative visit at 42 days +/- 7 days
Population: Patients undergoing uncomplicated phacoemulsification with lens implantation at a single center by a single surgeon.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolensa (Bromfenac 0.07%) | Retinal Thickness | 276 microns | Standard Deviation 1.26 |
| Ilevro (Nepafenac 0.3%) | Retinal Thickness | 279 microns | Standard Deviation 2.1 |