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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 19, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde Recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Raul Bustos, MD    36145501 ext 121    raulbustosz@yahoo.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: May 19, 2014
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:
Nepafenac
Ophthalmic Solutions
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014