Cataract, Phacoemulsification Cataract Surgery
Conditions
Keywords
bromfenac, nepafenac, cataract, phacoemulsification cataract surgery
Brief summary
The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.
Detailed description
Postsurgical inflammation is an inevitable condition after cataract surgery. The use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation. This is a phase II randomized double-blind clinical trial. The aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. Patients will be randomized to receive either PRO-155 or Nevanac for 60 days.
Interventions
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years who require cataract surgery * Both genders * Provide informed consent * Normal Laboratory results
Exclusion criteria
* Patients with visual acuity of 20/40 or less in the contralateral eye of the surgery * Patients with any trans-surgical complication * Patients with a cataract \>NC4, C4 or P4 classified with the system LOCS * Patients with any active corneal pathology * Patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or NSAIDs 7 days before the surgery (except low-dose aspirin) * Patients with IOP \<5 or \>21 mmHg * Patients that have ocular pain, cellularity or flare at the moment of selection * Patients with ocular exfoliation, trauma or any inflammatory disease * Patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus * Patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye * Patients with history of hypersensitivity or contraindication for any drug used in the study * Patients under anticoagulant treatment * Contact lens users * Pregnant patients, at risk of pregnancy or breastfeeding * Patients without birth control treatment * Patients with any active toxicomania (alcoholism, cigarette, cannabis or others) * Patients who had participated in any clinical trial in the last 90 days * Legal or mentally disabled patients who could not give informed consent * Patients who cannot comply with all study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Cellularity in Anterior Chamber | day 30 | Change from Percentage of Cellularity in anterior chamber after 30 days of treatment. |
| Flare in Anterior Chamber | day 30 | Percentage of Participants with flare in anterior chamber after 30 days of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Without Ocular Pain | day 30 | percentage of patients without pain, would be measured using the Visual Analog Pain Scale |
| Mean Aqueous Concentration of Intervention Drug | before surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Epithelial Defects Detected With Fluorescein | measurements will be made at days 1, 5, 7 and 30 | The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated |
| Epithelial Defects Detected With Green Lissamine | measurements will be made at days 1, 5, 7 and 30 | the percentage of patients presenting epithelial defects evaluated with green lysine will be reported |
| Intraocular Pressure | day 30 | Change from Baseline in the intraocular pressure after 30 days of treatment |
| Retinal Thickness | day 30 and 60 | Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery. |
Countries
Mexico
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| 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. | 70 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | PRO-155 | Nevanac | Total |
|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 11.1 | 68.0 years STANDARD_DEVIATION 9.5 | 67.7 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 69 Participants | 70 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mexico | 69 participants | 70 participants | 139 participants |
| Sex: Female, Male Female | 41 Participants | 39 Participants | 80 Participants |
| Sex: Female, Male Male | 28 Participants | 31 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 73 | 2 / 75 |
| serious Total, serious adverse events | 0 / 73 | 2 / 75 |
Outcome results
Primary
Flare in Anterior Chamber
Percentage of Participants with flare in anterior chamber after 30 days of treatment
Time frame: day 30
Population: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 | Flare in Anterior Chamber | Day 1 | 31.4 Percentage of Participants with flare |
| PRO-155 | Flare in Anterior Chamber | Day 30 | 0 Percentage of Participants with flare |
| Nevanac | Flare in Anterior Chamber | Day 1 | 31.5 Percentage of Participants with flare |
| Nevanac | Flare in Anterior Chamber | Day 30 | 0 Percentage of Participants with flare |
Primary
Percentage of Cellularity in Anterior Chamber
Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.
Time frame: day 30
Population: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 | Percentage of Cellularity in Anterior Chamber | Day 30 | 0 Percentage of Cellularity |
| PRO-155 | Percentage of Cellularity in Anterior Chamber | Day 1 | 64.2 Percentage of Cellularity |
| Nevanac | Percentage of Cellularity in Anterior Chamber | Day 30 | 0 Percentage of Cellularity |
| Nevanac | Percentage of Cellularity in Anterior Chamber | Day 1 | 64.3 Percentage of Cellularity |
p-value: 1Pearson´s Chi-square test
Secondary
Mean Aqueous Concentration of Intervention Drug
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.
Time frame: before surgery
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRO-155 | Mean Aqueous Concentration of Intervention Drug | 207.5 ng/mL | Standard Deviation 152.3 |
| Nevanac | Mean Aqueous Concentration of Intervention Drug | 314.4 ng/mL | Standard Deviation 146.5 |
Secondary
Percentage of Patients Without Ocular Pain
percentage of patients without pain, would be measured using the Visual Analog Pain Scale
Time frame: day 30
Population: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 | Percentage of Patients Without Ocular Pain | Day 1 | 6.1 percentage of patients |
| PRO-155 | Percentage of Patients Without Ocular Pain | Day 30 | 1.5 percentage of patients |
| Nevanac | Percentage of Patients Without Ocular Pain | Day 1 | 5.7 percentage of patients |
| Nevanac | Percentage of Patients Without Ocular Pain | Day 30 | 1.6 percentage of patients |
Other Pre-specified
Epithelial Defects Detected With Fluorescein
The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated
Time frame: measurements will be made at days 1, 5, 7 and 30
Population: Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 | Epithelial Defects Detected With Fluorescein | Day 1 | 54.4 percentage of patients with defects |
| PRO-155 | Epithelial Defects Detected With Fluorescein | Day 7 | 32.5 percentage of patients with defects |
| PRO-155 | Epithelial Defects Detected With Fluorescein | Day 15 | 15.6 percentage of patients with defects |
| PRO-155 | Epithelial Defects Detected With Fluorescein | Day 30 | 6 percentage of patients with defects |
| Nevanac | Epithelial Defects Detected With Fluorescein | Day 30 | 8.5 percentage of patients with defects |
| Nevanac | Epithelial Defects Detected With Fluorescein | Day 1 | 78.5 percentage of patients with defects |
| Nevanac | Epithelial Defects Detected With Fluorescein | Day 15 | 36.1 percentage of patients with defects |
| Nevanac | Epithelial Defects Detected With Fluorescein | Day 7 | 64.4 percentage of patients with defects |
Other Pre-specified
Epithelial Defects Detected With Green Lissamine
the percentage of patients presenting epithelial defects evaluated with green lysine will be reported
Time frame: measurements will be made at days 1, 5, 7 and 30
Population: Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-155 | Epithelial Defects Detected With Green Lissamine | Day 15 | 21.6 percentage of patients with defects |
| PRO-155 | Epithelial Defects Detected With Green Lissamine | Day 1 | 62.5 percentage of patients with defects |
| PRO-155 | Epithelial Defects Detected With Green Lissamine | Day 30 | 14.8 percentage of patients with defects |
| PRO-155 | Epithelial Defects Detected With Green Lissamine | Day 7 | 41.4 percentage of patients with defects |
| Nevanac | Epithelial Defects Detected With Green Lissamine | Day 30 | 28.2 percentage of patients with defects |
| Nevanac | Epithelial Defects Detected With Green Lissamine | Day 7 | 67.3 percentage of patients with defects |
| Nevanac | Epithelial Defects Detected With Green Lissamine | Day 1 | 86 percentage of patients with defects |
| Nevanac | Epithelial Defects Detected With Green Lissamine | Day 15 | 57.4 percentage of patients with defects |
Other Pre-specified
Intraocular Pressure
Change from Baseline in the intraocular pressure after 30 days of treatment
Time frame: day 30
Population: Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-155 | Intraocular Pressure | Day 15 | 13.81 mmHg | Standard Deviation 1.64 |
| PRO-155 | Intraocular Pressure | Day 30 | 14.10 mmHg | Standard Deviation 1.78 |
| PRO-155 | Intraocular Pressure | Day 0 | 14.07 mmHg | Standard Deviation 1.82 |
| PRO-155 | Intraocular Pressure | Day 1 | 14.66 mmHg | Standard Deviation 2.61 |
| PRO-155 | Intraocular Pressure | Day 7 | 14.13 mmHg | Standard Deviation 1.97 |
| Nevanac | Intraocular Pressure | Day 7 | 14.54 mmHg | Standard Deviation 1.85 |
| Nevanac | Intraocular Pressure | Day 15 | 13.91 mmHg | Standard Deviation 2.03 |
| Nevanac | Intraocular Pressure | Day 1 | 15.83 mmHg | Standard Deviation 2.77 |
| Nevanac | Intraocular Pressure | Day 30 | 13.77 mmHg | Standard Deviation 1.97 |
| Nevanac | Intraocular Pressure | Day 0 | 14.23 mmHg | Standard Deviation 1.9 |
Other Pre-specified
Retinal Thickness
Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.
Time frame: day 30 and 60
Population: Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-155 | Retinal Thickness | field A1 day 0 | 247.24 μm | Standard Deviation 32.9 |
| PRO-155 | Retinal Thickness | field A1 day 30 | 252.06 μm | Standard Deviation 24.95 |
| PRO-155 | Retinal Thickness | field A1 day 60 | 254.06 μm | Standard Deviation 2.78 |
| Nevanac | Retinal Thickness | field A1 day 0 | 250.87 μm | Standard Deviation 34.42 |
| Nevanac | Retinal Thickness | field A1 day 30 | 264.08 μm | Standard Deviation 34.1 |
| Nevanac | Retinal Thickness | field A1 day 60 | 260.13 μm | Standard Deviation 33.93 |