Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
NCT ID: NCT01657266
Last Updated: 2018-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2013-12-31
2015-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Interventions
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Nevanac
Pre-medication (before surgery) and maintenance treatment.
PRO-155
Pre-medication (before surgery) and maintenance treatment.
Eligibility Criteria
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Inclusion Criteria
* Both genders
* Provide informed consent
* Normal Laboratory results
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Laboratorios Sophia S.A de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Leopoldo M. Baiza-Durán, MD
Role: STUDY_DIRECTOR
Laboratorios Sophia S.A de C.V.
Locations
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Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Countries
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Related Links
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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
Other Identifiers
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SOPH155-0412/II
Identifier Type: -
Identifier Source: org_study_id
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