Trial Outcomes & Findings for Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification (NCT NCT01657266)
NCT ID: NCT01657266
Last Updated: 2018-10-30
Results Overview
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
day 30
Results posted on
2018-10-30
Participant Flow
160 subjects were recruited, 12 of whom were excluded, 10 because they did not meet the selection criteria and 2 refused to participate. The remaining 148 were randomly assigned to one of the 2 study groups, 73 to bromfenac and 75 to napaphenac.
Participant milestones
| Measure |
PRO-155
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
75
|
|
Overall Study
COMPLETED
|
69
|
70
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
PRO-155
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Adverse Event
|
2
|
3
|
Baseline Characteristics
Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
Baseline characteristics by cohort
| Measure |
PRO-155
n=69 Participants
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 Participants
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
69 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
139 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 30Population: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Outcome measures
| Measure |
PRO-155
n=69 Participants
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 Participants
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Percentage of Cellularity in Anterior Chamber
Day 1
|
64.2 Percentage of Cellularity
|
64.3 Percentage of Cellularity
|
|
Percentage of Cellularity in Anterior Chamber
Day 30
|
0 Percentage of Cellularity
|
0 Percentage of Cellularity
|
PRIMARY outcome
Timeframe: day 30Population: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Percentage of Participants with flare in anterior chamber after 30 days of treatment
Outcome measures
| Measure |
PRO-155
n=69 Participants
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 Participants
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Flare in Anterior Chamber
Day 1
|
31.4 Percentage of Participants with flare
|
31.5 Percentage of Participants with flare
|
|
Flare in Anterior Chamber
Day 30
|
0 Percentage of Participants with flare
|
0 Percentage of Participants with flare
|
SECONDARY outcome
Timeframe: day 30Population: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
percentage of patients without pain, would be measured using the Visual Analog Pain Scale
Outcome measures
| Measure |
PRO-155
n=69 Participants
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 Participants
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Percentage of Patients Without Ocular Pain
Day 1
|
6.1 percentage of patients
|
5.7 percentage of patients
|
|
Percentage of Patients Without Ocular Pain
Day 30
|
1.5 percentage of patients
|
1.6 percentage of patients
|
SECONDARY outcome
Timeframe: before surgeryPopulation: We enrolled patients of both sexes (aged \>18 years) with a diagnosis of cataract according to the Lens Opacities Classification System III ≤ NC4, C4 and, P4 in one eye were eligible for enrollment. Eligible patients must have had a best-corrected visual acuity of 6/60 (20/200) Snellen score.
a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification.
Outcome measures
| Measure |
PRO-155
n=69 eyes
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 eyes
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Mean Aqueous Concentration of Intervention Drug
|
207.5 ng/mL
Standard Deviation 152.3
|
314.4 ng/mL
Standard Deviation 146.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: measurements will be made at days 1, 5, 7 and 30Population: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated
Outcome measures
| Measure |
PRO-155
n=69 Participants
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 Participants
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Epithelial Defects Detected With Fluorescein
Day 1
|
54.4 percentage of patients with defects
|
78.5 percentage of patients with defects
|
|
Epithelial Defects Detected With Fluorescein
Day 7
|
32.5 percentage of patients with defects
|
64.4 percentage of patients with defects
|
|
Epithelial Defects Detected With Fluorescein
Day 15
|
15.6 percentage of patients with defects
|
36.1 percentage of patients with defects
|
|
Epithelial Defects Detected With Fluorescein
Day 30
|
6 percentage of patients with defects
|
8.5 percentage of patients with defects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: measurements will be made at days 1, 5, 7 and 30Population: Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
the percentage of patients presenting epithelial defects evaluated with green lysine will be reported
Outcome measures
| Measure |
PRO-155
n=69 Participants
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 Participants
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Epithelial Defects Detected With Green Lissamine
Day 15
|
21.6 percentage of patients with defects
|
57.4 percentage of patients with defects
|
|
Epithelial Defects Detected With Green Lissamine
Day 30
|
14.8 percentage of patients with defects
|
28.2 percentage of patients with defects
|
|
Epithelial Defects Detected With Green Lissamine
Day 1
|
62.5 percentage of patients with defects
|
86 percentage of patients with defects
|
|
Epithelial Defects Detected With Green Lissamine
Day 7
|
41.4 percentage of patients with defects
|
67.3 percentage of patients with defects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 30Population: Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Change from Baseline in the intraocular pressure after 30 days of treatment
Outcome measures
| Measure |
PRO-155
n=69 Participants
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 Participants
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Intraocular Pressure
Day 0
|
14.07 mmHg
Standard Deviation 1.82
|
14.23 mmHg
Standard Deviation 1.90
|
|
Intraocular Pressure
Day 1
|
14.66 mmHg
Standard Deviation 2.61
|
15.83 mmHg
Standard Deviation 2.77
|
|
Intraocular Pressure
Day 7
|
14.13 mmHg
Standard Deviation 1.97
|
14.54 mmHg
Standard Deviation 1.85
|
|
Intraocular Pressure
Day 15
|
13.81 mmHg
Standard Deviation 1.64
|
13.91 mmHg
Standard Deviation 2.03
|
|
Intraocular Pressure
Day 30
|
14.10 mmHg
Standard Deviation 1.78
|
13.77 mmHg
Standard Deviation 1.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 30 and 60Population: Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.
Outcome measures
| Measure |
PRO-155
n=69 Participants
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=70 Participants
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Retinal Thickness
field A1 day 30
|
252.06 μm
Standard Deviation 24.95
|
264.08 μm
Standard Deviation 34.10
|
|
Retinal Thickness
field A1 day 0
|
247.24 μm
Standard Deviation 32.90
|
250.87 μm
Standard Deviation 34.42
|
|
Retinal Thickness
field A1 day 60
|
254.06 μm
Standard Deviation 2.78
|
260.13 μm
Standard Deviation 33.93
|
Adverse Events
PRO-155
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Nevanac
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PRO-155
n=73 participants at risk
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=75 participants at risk
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/73 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
1.3%
1/75 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
|
Eye disorders
central retinal artery occlusion
|
0.00%
0/73 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
1.3%
1/75 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
Other adverse events
| Measure |
PRO-155
n=73 participants at risk
Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
PRO-155: Pre-medication (before surgery) and maintenance treatment.
|
Nevanac
n=75 participants at risk
Nepafenac 0.1% (1mg/mL) Ophthalmic Suspension
Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye
Maintenance therapy: 1 drop 3 times a day for 30 days
Nevanac: Pre-medication (before surgery) and maintenance treatment.
|
|---|---|---|
|
Eye disorders
viral conjunctivitis
|
1.4%
1/73 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
0.00%
0/75 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
|
Eye disorders
Inflammatory cells in the corneal endothelium
|
1.4%
1/73 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
0.00%
0/75 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
|
Eye disorders
intraocular lens exchange
|
0.00%
0/73 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
1.3%
1/75 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
|
Vascular disorders
fall from their own height
|
0.00%
0/73 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
1.3%
1/75 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
|
Eye disorders
Cystoid macular edema
|
1.4%
1/73 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
0.00%
0/75 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
|
Eye disorders
Traumatic corneal desepithelization
|
1.4%
1/73 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
0.00%
0/75 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
|
Eye disorders
Posterior Capsular Rupture
|
1.4%
1/73 • Number of events 1 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
0.00%
0/75 • Interval of 30 days of intervention in which adverse events could occur, included in the treatment period (January 2014-2015)
During the pharmacological intervention period, in each visit, the principal investigator asked information about adverse events: 1. Serious or No serious 2. Severity: mild, moderate, severe 3. relation with study drug or not
|
Additional Information
Leopoldo M Baiza-Duran MD, Clinical trials Director
Laboratorios Sophia S.A. de C.V.
Phone: 52+ (33) 30 01 42 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All the information is confidential and exclusive property of the sponsor. Information can be revealed only to my staff and regulatory agencies or ethics committee. All the information from this protocol is confidential and exclusive property of the sponsor, it can not be revealed without written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER