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

Information source: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: PRO-155 (Drug); Nevanac (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Laboratorios Sophia S.A de C.V.

Overall contact:
Leopoldo M Baiza-Durán, MD, Phone: +52(33) 30014200, Ext: 1051, Email: lbaiza@sophia.com.mx

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

cellularity in anterior chamber

flare in anterior chamber

Secondary outcome: Ocular pain

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 toxicomanies (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

Locations and Contacts

Leopoldo M Baiza-Durán, MD, Phone: +52(33) 30014200, Ext: 1051, Email: lbaiza@sophia.com.mx

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco 44280, Mexico; Recruiting
Raul Bustos, MD, Phone: 36145501, Ext: 121, Email: raulbustosz@yahoo.mx
Additional Information

Starting date: December 2013
Last updated: May 19, 2014

Page last updated: August 23, 2015

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