Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%

March 3, 2017 updated by: MDbackline, LLC
This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one eye of each subject. The study will follow good clinical practices (GCP). The primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Harvard Eye Associates
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Cincinnati Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients 18 years and older currently undergoing femtosecond or manual cataract surgery with or without astigmatic keratotomy.
  2. Patients willing to take an electronic survey about their tolerability of either study medication.

Exclusion Criteria

  1. Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings.

  2. Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:

    1. Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure.
    2. Clinically significant ocular trauma.
    3. Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
    4. Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
    5. Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)
  3. Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
  4. Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
  5. Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
  6. Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
  7. Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
  8. Participation in this trial in the same patient's fellow eye.
  9. Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: nepafenac 0.3%
Patients in this arm will receive nepafenac 0.3% eye drops once daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care.
Drug: nepafenac 0.3%
Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery.
Other Names:
  • Ilevro
Active Comparator: ketorolac 0.5%
Patients in this arm will receive ketorolac 0.5% eye drops four times daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care.
Drug: ketorolac
Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of nepafenac vs ketorolac
Time Frame: 14-28 days
Patients will fill out a survey describing eye drop tolerability at 14-28 days
14-28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MDbackline, LLC

Collaborators

Alcon Research

Investigators

  • Principal Investigator: John A Hovanesian, MD, UCLA Jules Stein Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALC-15417759

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make individual patient data available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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