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The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Sponsor
Virginia Polytechnic Institute and State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05542381
Collaborator
Vistar Eye Center (Other)
72
Enrollment
3
Arms
26
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, nepafenac (NSAID comparison), or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.

Condition or Disease Intervention/Treatment Phase
  • Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]
  • Drug: Nepafenac Ophthalmic 0.3% Ophthalmic Suspension
  • Other: Refresh Lubricant Eye Drops [Artificial Tears]
 N/A

Detailed Description

Patients are already receiving an intravitreal injection as a standard of care for age-related macular degeneration, but they are consenting to receiving a loteprednol drop following the intravitreal injection for the research study. Loteprednol is used as a part of regular medical care at the Vistar Eye Center following intravitreal injections but quantifying the magnitude of pain reduction has not been done yet. Additionally, as of now there is no definitive pain management technique following intravitreal injections. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants will be treated with either loteprednol, nepafenac (NSAID comparison), or artificial tears following one visit for an intravitreal injection at the Vistar Eye Center to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at 2-hours, 1-day, and 1-week following the intravitreal injection. Intravitreal injections will be performed by the retina surgeon, and phone calls will be done with the research coordinator. Artificial tear and medication usage will also be tracked over a 1-week period.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blinded placebo-controlled designDouble-blinded placebo-controlled design
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The study design is a double-blinded placebo-controlled experiment, as the patient and the investigator recording the pain scores will not know which treatment arm the patient is assigned to (negative control, comparison group, or experimental group).
Primary Purpose:
Treatment
Official Title:
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Loteprednol

1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm.

Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]
Loteprednol (ophthalmic corticosteroid) will be stored in the clinic according to the instructions on the package. The vial will be stored upright between 15°-25°C (59°-77°F). In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection.
Active Comparator: Nepafenac (NSAID Comparison)

1 drop of Nepafenac is administered immediately after the intravitreal injection in this treatment arm. This is used as an NSAID comparison based on previous studies.

Drug: Nepafenac Ophthalmic 0.3% Ophthalmic Suspension
Nepafenac (ophthalmic NSAID) will be stored in the clinic according to the instructions on the package. The vial will be stored upright between 2 - 25˚C (36 - 77˚F). In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection.
Placebo Comparator: Artificial tears

1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control.

Other: Refresh Lubricant Eye Drops [Artificial Tears]
REFRESH® Brand Lubricant Eye Drops are artificial tears. In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection.
Other Names:
  • Refresh

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-Intravitreal Injection Pain [2-hour Post-Intravitreal Injection]

      11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)

    2. Post-Intravitreal Injection Pain [1-day Post-Intravitreal Injection]

      11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)

    3. Post-Intravitreal Injection Pain [1-week Post-Intravitreal Injection]

      11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)

    Secondary Outcome Measures

    1. Analgesic Medication Use [2-hour Post-Intravitreal Injection]

      Pill count

    2. Analgesic Medication Use [1-day Post-Intravitreal Injection]

      Pill count

    3. Analgesic Medication Use [1-week Post-Intravitreal Injection]

      Pill count

    4. Artificial Tear Use [2-hour Post-Intravitreal Injection]

      Artificial Tear Drop Count

    5. Artificial Tear Use [1-day Post-Intravitreal Injection]

      Artificial Tear Drop Count

    6. Artificial Tear Use [1-week Post-Intravitreal Injection]

      Artificial Tear Drop Count

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.
    Exclusion Criteria:

    • Dementia

    • Report baseline eye pain

    • Use topical NSAIDs or steroids

    • Patient under 18 years old

    • History of corticosteroid responsive elevation in intraocular pressure

    • Allergy to Loteprednol or Nepafenac

    • Pre-existing chronic pain disorders

    • Advanced Glaucoma

    • Herpes zoster

    • Allergy to local anesthetic or penicillin

    • Patients unable to consent on own behalf

    • Patients unable to communicate pain

    • Pregnancy

    • Incarceration

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Virginia Polytechnic Institute and State University
    • Vistar Eye Center

    Investigators

    • Principal Investigator: Vishak John, MD, Vistar Eye Center
    • Principal Investigator: Romulo Albuquerque, M.D., Ph.D., Vistar Eye Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Vishak John, Retina Surgeon, Virginia Polytechnic Institute and State University
    ClinicalTrials.gov Identifier:
    NCT05542381
    Other Study ID Numbers:
    • 22-514
    First Posted:
    Sep 15, 2022
    Last Update Posted:
    Sep 15, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Vishak John, Retina Surgeon, Virginia Polytechnic Institute and State University
    Loteprednol
    Loteprednol Etabonate Ophthalmic Suspension
    Immunosuppressive Agents
    Glucocorticoids
    Immunologic Factors
    Molecular Mechanisms of Pharmacological Action
    Eye Diseases
    Retinal Diseases
    Anti-Inflammatory Agents
    vascular endothelial growth factor
    Intravitreal Injection
    Post-Intravitreal Injection Pain
    Additional relevant MeSH terms:
    Macular Degeneration
    Loteprednol Etabonate
    Nepafenac
    Ophthalmic Solutions
    Lubricant Eye Drops

    Study Results

    No Results Posted as of Sep 15, 2022