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

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ClinicalTrials.gov Identifier: NCT01657266
Recruitment Status : Unknown
Verified May 2014 by Laboratorios Sophia S.A de C.V..
Recruitment status was:  Recruiting
First Posted : August 6, 2012
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Laboratorios Sophia S.A de C.V.

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

Condition or disease Intervention/treatment Phase
Cataract Drug: PRO-155 Drug: Nevanac Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
Drug Information available for: Nepafenac
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. cellularity in anterior chamber [ Time Frame: day 60 ]
    Change from Baseline in cellularity in anterior chamber after 60 days of treatment

  2. flare in anterior chamber [ Time Frame: day 60 ]
    Change from Baseline in flare in anterior chamber after 60 days of treatment


Secondary Outcome Measures :
  1. Ocular pain [ Time Frame: day 60 ]
    Number of patients without pain, would be measured using the Visual Analog Pain Scale


Other Outcome Measures:
  1. fluorescein dye [ Time Frame: day 60 ]
    Number of patients with normal fluorescein dye

  2. green lissamine dye [ Time Frame: day 60 ]
    Number of patients with normal green lissamine dye



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Laboratorios Sophia S.A de C.V.
ClinicalTrials.gov Identifier: NCT01657266     History of Changes
Other Study ID Numbers: SOPH155-0412/II
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Nepafenac
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents