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

NCT05542381 | Completed

• 1 other identifier: 22-514
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Age-Related Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Post-Intravitreal Injection Pain

  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

  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

  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 Outcomes (6)

• Analgesic Medication Use

  2-hour Post-Intravitreal Injection

• Analgesic Medication Use

  1-day Post-Intravitreal Injection

• Analgesic Medication Use

  1-week Post-Intravitreal Injection

• Artificial Tear Use

  2-hour Post-Intravitreal Injection

• Artificial Tear Use

  1-day Post-Intravitreal Injection

Study Arms (2)

Loteprednol

EXPERIMENTAL

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

Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]

Artificial tears

PLACEBO COMPARATOR

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]

Interventions

Loteprednol Etabonate Ophthalmic Gel [Lotemax] DRUG

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.

Loteprednol

Refresh Lubricant Eye Drops [Artificial Tears] OTHER

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.

Also known as: Refresh

Artificial tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Vistar Eye Center: collaborator

Study Sites (1)

Vistar Eye Center

Roanoke, Virginia, 24019, United States

Location

Related Publications (19)

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  PMID: 11150074 BACKGROUND

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Related Links

• Lotemax Information

MeSH Terms

Conditions

Macular Degeneration; Eye Diseases; Retinal Diseases

Interventions

Loteprednol Etabonate; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Retinal Degeneration

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Vishak John, MD

  Vistar Eye Center

  PRINCIPAL INVESTIGATOR

• Romulo Albuquerque, M.D., Ph.D.

  Vistar Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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 or experimental group).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Retina Surgeon

Model Details: Double-blinded placebo-controlled design

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 15, 2022
• Study Start: December 22, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)