Efficacy and Safety of PRO-155 Versus Nevanac in Post Phacoemulsification

Laboratorios Sophia

Status and phase: Completed; Phase 2

Conditions: Phacoemulsification Cataract Surgery; Cataract

Treatments: Drug: PRO-155; Drug: Nevanac

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657266

SOPH155-0412/II

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-155 in patients post phacoemulsification.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

PRO-155

Experimental group

Description:

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

Treatment:

Drug: PRO-155

Nevanac

Active Comparator group

Description:

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

Treatment:

Drug: Nevanac