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

January 18, 2024 updated by: Vishak John, Virginia Polytechnic Institute and State University
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, 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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, 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 Type

Interventional

Enrollment (Estimated)

72

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 Contact

  • Name: Paul K Varghese
  • Phone Number: 7033999886
  • Email: paulv@vt.edu

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24019
        • Recruiting
        • Vistar Eye Center
        • Contact:
          • Vishak John, MD
          • Phone Number: 540-855-5100

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Triple

Arms and Interventions

Participant Group / 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Intravitreal Injection Pain
Time Frame: 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-hour Post-Intravitreal Injection
Post-Intravitreal Injection Pain
Time Frame: 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)
1-day Post-Intravitreal Injection
Post-Intravitreal Injection Pain
Time Frame: 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)
1-week Post-Intravitreal Injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic Medication Use
Time Frame: 2-hour Post-Intravitreal Injection
Pill count
2-hour Post-Intravitreal Injection
Analgesic Medication Use
Time Frame: 1-day Post-Intravitreal Injection
Pill count
1-day Post-Intravitreal Injection
Analgesic Medication Use
Time Frame: 1-week Post-Intravitreal Injection
Pill count
1-week Post-Intravitreal Injection
Artificial Tear Use
Time Frame: 2-hour Post-Intravitreal Injection
Artificial Tear Drop Count
2-hour Post-Intravitreal Injection
Artificial Tear Use
Time Frame: 1-day Post-Intravitreal Injection
Artificial Tear Drop Count
1-day Post-Intravitreal Injection
Artificial Tear Use
Time Frame: 1-week Post-Intravitreal Injection
Artificial Tear Drop Count
1-week Post-Intravitreal Injection

Collaborators and Investigators

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

Sponsor

Virginia Polytechnic Institute and State University

Collaborators

Vistar Eye Center

Investigators

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

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

Helpful Links

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 (Actual)

December 22, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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