Clinical trial NCT01657266: Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification
Official title: Phase 2 Randomized, Double-blind Clinical Trial to Evaluate Efficacy and Safety of the Ophthalmic Solution PRO-155 Versus Nevanac 0.1% Ophthalmic Solution in Post Phacoemulsification Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract
Phacoemulsification Cataract Surgery
Keywords: bromfenac
nepafenac
cataract
phacoemulsification cataract surgery
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Cellularity in Anterior Chamber
timeFrame: day 30
measure: Flare in Anterior Chamber
timeFrame: day 30
Secondary outcomes:
measure: Percentage of Patients Without Ocular Pain
timeFrame: day 30
measure: Mean Aqueous Concentration of Intervention Drug
timeFrame: before surgery
Other outcomes:
measure: Epithelial Defects Detected With Fluorescein
timeFrame: measurements will be made at days 1, 5, 7 and 30
measure: Epithelial Defects Detected With Green Lissamine
timeFrame: measurements will be made at days 1, 5, 7 and 30
measure: Intraocular Pressure
timeFrame: day 30
measure: Retinal Thickness
timeFrame: day 30 and 60
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Laboratorios Sophia S.A de C.V.
name: Leopoldo M. Baiza-Durán, MD
role: STUDY_DIRECTOR
References: