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COMPLETED NA

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

NCT05542381 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Loteprednol Etabonate Ophthalmic Gel [Lotemax]
  • OTHER Refresh Lubricant Eye Drops [Artificial Tears]

Study Locations (1)

Virginia

  • Vistar Eye Center — Roanoke

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2022-12-22
Est. Completion 2025-05-01
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05542381

The ClinicalTrials.gov registry entry for NCT05542381 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Polytechnic Institute and State University, which has 93 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05542381 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05542381?

This trial is sponsored by Virginia Polytechnic Institute and State University, which has 93 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial