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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01657266
Recruitment Status : Completed
First Posted : August 6, 2012
Results First Posted : October 30, 2018
Last Update Posted : October 30, 2018
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 Phacoemulsification Cataract Surgery 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 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
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
Drug Information available for: Nepafenac

Arm Intervention/treatment
Experimental: PRO-155

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

Drug: PRO-155
Pre-medication (before surgery) and maintenance treatment.

Active Comparator: Nevanac

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

Drug: Nevanac
Pre-medication (before surgery) and maintenance treatment.




Primary Outcome Measures :
  1. Percentage of Cellularity in Anterior Chamber [ Time Frame: day 30 ]
    Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.

  2. Flare in Anterior Chamber [ Time Frame: day 30 ]
    Percentage of Participants with flare in anterior chamber after 30 days of treatment


Secondary Outcome Measures :
  1. Percentage of Patients Without Ocular Pain [ Time Frame: day 30 ]
    percentage of patients without pain, would be measured using the Visual Analog Pain Scale

  2. Mean Aqueous Concentration of Intervention Drug [ Time Frame: before surgery ]
    a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification.


Other Outcome Measures:
  1. Epithelial Defects Detected With Fluorescein [ Time Frame: measurements will be made at days 1, 5, 7 and 30 ]
    The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated

  2. Epithelial Defects Detected With Green Lissamine [ Time Frame: measurements will be made at days 1, 5, 7 and 30 ]
    the percentage of patients presenting epithelial defects evaluated with green lysine will be reported

  3. Intraocular Pressure [ Time Frame: day 30 ]
    Change from Baseline in the intraocular pressure after 30 days of treatment

  4. Retinal Thickness [ Time Frame: day 30 and 60 ]
    Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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

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


Locations
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Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Sponsors and Collaborators
Laboratorios Sophia S.A de C.V.
Investigators
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Study Director: Leopoldo M. Baiza-Durán, MD Laboratorios Sophia S.A de C.V.

Additional Information:
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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
Results First Posted: October 30, 2018
Last Update Posted: October 30, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The personal data were collected and analyzed according to confidentiality policy.

Keywords provided by Laboratorios Sophia S.A de C.V.:
bromfenac
nepafenac
cataract
phacoemulsification cataract surgery

Additional relevant MeSH terms:
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Cataract
Eye Diseases
Ophthalmic Solutions
Lens Diseases
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