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The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-155 | Experimental | 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 |
|
| Nevanac | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-155 | Drug | Pre-medication (before surgery) and maintenance treatment. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Cellularity in Anterior Chamber | Change from Percentage of Cellularity in anterior chamber after 30 days of treatment. | day 30 |
| Flare in Anterior Chamber | Percentage of Participants with flare in anterior chamber after 30 days of treatment | day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Without Ocular Pain | percentage of patients without pain, would be measured using the Visual Analog Pain Scale | day 30 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Epithelial Defects Detected With Fluorescein | The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated | measurements will be made at days 1, 5, 7 and 30 |
| Epithelial Defects Detected With Green Lissamine |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo M. Baiza-Durán, MD | Laboratorios Sophia S.A de C.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
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| Label | URL |
|---|---|
| Palacio C, et al. Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population. Clinical Ophthalmology 2016;10:233-237 | View source |
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The personal data were collected and analyzed according to confidentiality policy.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Mexican patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Nevanac |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Cellularity in Anterior Chamber | Change from Percentage of Cellularity in anterior chamber after 30 days of treatment. | Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation. | Posted | Number | Percentage of Cellularity | day 30 |
|
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:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhegmatogenous retinal detachment | Eye disorders | Systematic Assessment | This serious adverse event occurred during the systematic assessment. The event was not related with the pharmacological intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fall from their own height | Vascular disorders | Systematic Assessment | The mild adverse event does not have relationship with the study drug. |
The study was performed according to the clinical protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leopoldo M Baiza-Duran MD, Clinical trials Director | Laboratorios Sophia S.A. de C.V. | 52+ (33) 30 01 42 00 | leopoldo.baiza@sophia.com.mx |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
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| Nevanac |
| Drug |
Pre-medication (before surgery) and maintenance treatment. |
|
| before surgery |
the percentage of patients presenting epithelial defects evaluated with green lysine will be reported
| measurements will be made at days 1, 5, 7 and 30 |
| Intraocular Pressure | Change from Baseline in the intraocular pressure after 30 days of treatment | day 30 |
| 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. | day 30 and 60 |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Flare in Anterior Chamber | Percentage of Participants with flare in anterior chamber after 30 days of treatment | Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation. | Posted | Number | Percentage of Participants with flare | day 30 |
|
|
|
| Secondary | Percentage of Patients Without Ocular Pain | percentage of patients without pain, would be measured using the Visual Analog Pain Scale | Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation. | Posted | Number | percentage of patients | day 30 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | before surgery | eyes | eyes |
|
|
|
| Other Pre-specified | Epithelial Defects Detected With Fluorescein | The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated | Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation. | Posted | Number | percentage of patients with defects | measurements will be made at days 1, 5, 7 and 30 |
|
|
|
| Other Pre-specified | Epithelial Defects Detected With Green Lissamine | the percentage of patients presenting epithelial defects evaluated with green lysine will be reported | Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation. | Posted | Number | percentage of patients with defects | measurements will be made at days 1, 5, 7 and 30 |
|
|
|
| Other Pre-specified | Intraocular Pressure | Change from Baseline in the intraocular pressure after 30 days of treatment | Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation. | Posted | Mean | Standard Deviation | mmHg | day 30 |
|
|
|
| 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. | Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation. | Posted | Mean | Standard Deviation | μm | day 30 and 60 |
|
|
|
| 0 |
| 73 |
| 5 |
| 73 |
| EG001 | 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. | 2 | 75 | 2 | 75 |
|
| central retinal artery occlusion | Eye disorders | Systematic Assessment | This serious adverse event occurred during systematic assessment. The adverse event was not related with the pharmacological intervention. |
|
|
| Cystoid macular edema | Eye disorders | Systematic Assessment | This moderate adverse event does not relationship with the study drug. The clinically significant cystoid macular edema occurs after cataract surgery. |
|
| Traumatic corneal desepithelization | Eye disorders | Systematic Assessment | This moderate event does not have relationship with the study drug. The patient presented an accidental ocular injure. |
|
| Posterior Capsular Rupture | Eye disorders | Systematic Assessment | This mild adverse event does not relationship with the study drug. The posterior capsular rupture occurs after cataract surgery. |
|
| viral conjunctivitis | Eye disorders | Systematic Assessment | This severe adverse event does not have relationship with the study drug. This patient had hypothyroidism like concomitant disease, this clinical condition would be able to increase the risk to have an infectious disease. |
|
| Inflammatory cells in the corneal endothelium | Eye disorders | Systematic Assessment | This moderate adverse event does not have relationship with the study drug. The presence of inflammatory cells in the corneal endothelium is related to cataract surgery procedure. |
|
| intraocular lens exchange | Eye disorders | Systematic Assessment | This adverse event does not have relationship with the study drug. The reason of intraocular lens exchange was: error in the intraocular lens power calculation. |
|
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.
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