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

This study is not yet open for participant recruitment.
Verified June 2013 by Laboratorios Sophia S.A de C.V.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier:
NCT01657266
First received: July 19, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Cataract
Drug: PRO-155
Drug: Nevanac
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Laboratorios Sophia S.A de C.V.:

Primary Outcome Measures:
  • cellularity in anterior chamber [ Time Frame: day 60 ] [ Designated as safety issue: No ]
    Change from Baseline in cellularity in anterior chamber after 60 days of treatment

  • flare in anterior chamber [ Time Frame: day 60 ] [ Designated as safety issue: No ]
    Change from Baseline in flare in anterior chamber after 60 days of treatment


Secondary Outcome Measures:
  • Ocular pain [ Time Frame: day 60 ] [ Designated as safety issue: No ]
    Number of patients without pain, would be measured using the Visual Analog Pain Scale


Other Outcome Measures:
  • fluorescein dye [ Time Frame: day 60 ] [ Designated as safety issue: Yes ]
    Number of patients with normal fluorescein dye

  • green lissamine dye [ Time Frame: day 60 ] [ Designated as safety issue: Yes ]
    Number of patients with normal green lissamine dye


Estimated Enrollment: 150
Study Start Date: December 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRO-155
PRO-155 ophthalmic solution
Drug: PRO-155
instill one drop 2 times a day (BID) for 30 days
Active Comparator: Nevanac
Nepafenac Ophthalmic Solution 0.1%
Drug: Nevanac
instill one drop 2 times a day (BID) for 30 days
Other Name: Nepafenac

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657266

Contacts
Contact: Leopoldo M Baiza-Durán, MD +52(33) 30014200 ext 1051 lbaiza@sophia.com.mx
Contact: Clotilde Ayala-Barajas, MSc +52(33) 30014200 ext 1074 clotilde.ayala@sophia.com.mx

Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
  More Information

No publications provided

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01657266     History of Changes
Other Study ID Numbers: SOPH155-0412/II
Study First Received: July 19, 2012
Last Updated: June 3, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014