Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%

• Sponsor: Toyos Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01310127
• Collaborator: Bausch & Lomb Incorporated (Industry)
• Enrollment: 23
• Arms: 2
• Duration (Months): 5.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Pseudophakia	Drug: Bromfenac; Drug: Nepafenac	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1% TID for Treatment of Ocular Inflammation Associated With Cataract Surgery
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bromday 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; bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery; Other Names: Bromday (bromfenac ophthalmic solution) 0.9%
Active Comparator: Nevanac 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; 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; Other Names: Nevanac (nepafenac ophthamic suspension) 0.1%

Outcome Measures

Primary Outcome Measures

1. Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities [Week 6]

   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.

2. Summed Ocular Inflammation Score (SOIS) [Week 6]

   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).

3. OCT Retinal Thickness [Week 6]

   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.

4. Macular Volume [6 weeks]

   Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Are male or female at least 18 years of age who are scheduled for unilateral cataract surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens implantation and for whom no other ophthalmic surgical procedures (e.g., relaxing incisions, iridectomy, conjunctival excisions, etc) are to be conducted 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.

• If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

• Have IOP ≥ 5 mmHg and ≤ 22 mmHg (in study eye) with or without anti glaucoma therapy at the pre operative screening visit (if >22 mmHg, adjust following pachymetry).

Exclusion Criteria:

• Have known hypersensitivity to bromfenac or Nepafenac or to 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 to other non steroidal anti inflammatory drugs (NSAIDs).

• Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in the study eye at the 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 the study.

• Have used any ocular prostaglandins within 30 days prior to initiation of dosing with the test article or throughout the duration of the study.

• Have active corneal pathology noted in the study eye at the 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 the study eye is a criterion for exclusion.

• 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.

• Are pregnant or nursing/lactating.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Toyos Clinic
• Bausch & Lomb Incorporated

Investigators

• Principal Investigator: Melissa Cable, MD, Discover Vision Centers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Melissa Toyos, Principal Inevstigator, Toyos Clinic
• ClinicalTrials.gov Identifier: NCT01310127
• Other Study ID Numbers: MAC-02-11
• First Posted: Mar 8, 2011
• Last Update Posted: Oct 28, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Melissa Toyos, Principal Inevstigator, Toyos Clinic: NSAID; Ocular Inflammation; bromfenac
• Additional relevant MeSH terms: Inflammation; Pseudophakia; Nepafenac; Bromfenac; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	Subjects were randomized to receive bromfenac(n=12) QD or nepafenac(n=11) TID. Dosing was 3 days before cataract surgery through day 21 postop. Subjects could not have used ocular/topical, systemic NSAIDs, gentamicin, or cyclosporine ophthalmic emulsion 7 days or prostaglandins 30 days prior to initial dosing of test article or during the study.

Arm/Group Title	Bromday	Nevanac
Arm/Group Description	Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery	Nepafenac : 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
Period Title: Overall Study
STARTED	12	11
COMPLETED	10	10
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Bromday	Nevanac	Total
Arm/Group Description	Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery	Nepafenac : 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	Total of all reporting groups
Overall Participants	12	11	23
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 91.7%	10 90.9%	21 91.3%
>=65 years	1 8.3%	1 9.1%	2 8.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.1 (10.5)	69.7 (9.0)	69.9 (9.5)
Sex: Female, Male (Count of Participants)
Female	5 41.7%	6 54.5%	11 47.8%
Male	7 58.3%	5 45.5%	12 52.2%
Region of Enrollment (participants) [Number]
United States	12 100%	11 100%	23 100%

Outcome Measures

1. Primary Outcome

Title	Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bromday	Nevanac
Arm/Group Description	Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery	Nepafenac : 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
Measure Participants	10	10
Mean (Standard Deviation) [letters]	51.3 (6.818)	52 (6.750)

2. Primary Outcome

Title	Summed Ocular Inflammation Score (SOIS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bromday	Nevanac
Arm/Group Description	Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery	Nepafenac : 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
Measure Participants	10	10
Mean (Standard Deviation) [units on a scale]	0.15 (0.229)	0.2 (0.245)

3. Primary Outcome

Title	OCT Retinal Thickness
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bromday	Nevanac
Arm/Group Description	Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery	Nepafenac : 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
Measure Participants	10	10
Mean (Standard Deviation) [micrometers cubed]	230.7 (30.63)	223.8 (25.36)

4. Primary Outcome

Title	Macular Volume
Description	Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bromday	Nevanac
Arm/Group Description	Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery	Nepafenac : 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
Measure Participants	10	10
Mean (Standard Deviation) [mm cubed]	0.1815 (0.49)	0.1765 (0.34)

Adverse Events

Arm/Group Title	Bromday		Nevanac
Arm/Group Description	Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery		Nepafenac : 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
All Cause Mortality
	Bromday		Nevanac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bromday		Nevanac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Bromday		Nevanac
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		1/11 (9.1%)
Eye disorders
recurrent symptomatic postoperative iritis	0/12 (0%)	0	1/11 (9.1%)	1

Limitations/Caveats

The major limitation in the study is that it was a small pilot study so that the direct correlations of the study variable could not be evaluated. There were ethnic differences in the groups that could also influence the data.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.