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NCT05542381 · ClinicalTrials.gov registry record · NA
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
A NA study of Age-related Macular Degeneration, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT05542381: Completed NA study of Age-related Macular Degeneration, sponsored by Virginia Polytechnic Institute and State University.
NCT05542381 is a NA study of Age-related Macular Degeneration that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 64 participants, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05542381, a NA study of Age-related Macular Degeneration, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Conditions Studied
Interventions
- DRUG Loteprednol Etabonate Ophthalmic Gel [Lotemax]
- OTHER Refresh Lubricant Eye Drops [Artificial Tears]
Study Locations (1)
Virginia
- Vistar Eye Center - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2022-12-22 |
| Est. Completion | 2025-05-01 |
| Phase | NA |
What the finished NCT05542381 record still lists
NCT05542381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which Loteprednol Etabonate Ophthalmic Gel [Lotemax] is the first listed.
NCT05542381 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05542381 about?
NCT05542381 is a clinical study titled "The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain". 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 fo...
What is the current status of trial NCT05542381?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2022-12-22. Estimated completion is 2025-05-01.
What conditions does trial NCT05542381 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
What interventions are being tested in trial NCT05542381?
The interventions under investigation include: Loteprednol Etabonate Ophthalmic Gel [Lotemax] (DRUG), Refresh Lubricant Eye Drops [Artificial Tears] (OTHER).
Who is sponsoring clinical trial NCT05542381?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05542381 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05542381's enrollment target sits among peer trials
64 41st of 74 higher than 34 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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