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Completed

NCT Number: NCT01657266

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Phacoemulsification Cataract Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRO-155

Drug

Pre-medication (before surgery) and maintenance treatment.

Nevanac

Drug

Pre-medication (before surgery) and maintenance treatment.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Laboratorios Sophia S.A de C.V.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2012
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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