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

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ClinicalTrials.gov Identifier: NCT02752646
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
MDbackline, LLC

Brief Summary:
This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.

Condition or disease Intervention/treatment Phase
Cataract Drug: nepafenac 0.3% Drug: ketorolac Not Applicable

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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%
Study Start Date : April 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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 Name: 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.




Primary Outcome Measures :
  1. Tolerability of nepafenac vs ketorolac [ Time Frame: 14-28 days ]
    Patients will fill out a survey describing eye drop tolerability at 14-28 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02752646


Locations
United States, California
Harvard Eye Associates
Laguna Hills, California, United States, 92653
United States, Kentucky
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
Sponsors and Collaborators
MDbackline, LLC
Alcon Research
Investigators
Principal Investigator: John A Hovanesian, MD UCLA Jules Stein Eye Institute

Publications of Results:
Responsible Party: MDbackline, LLC
ClinicalTrials.gov Identifier: NCT02752646     History of Changes
Other Study ID Numbers: ALC-15417759
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual patient data available.

Keywords provided by MDbackline, LLC:
cataract

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action