Clinical trial
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
Name
22-514
Description
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.
Trial arms
Trial start
2022-12-22
Estimated PCD
2024-09-01
Trial end
2024-12-01
Status
Recruiting
Treatment
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.
Arms:
Loteprednol
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.
Arms:
Artificial tears
Other names:
Refresh
Size
72
Primary endpoint
Post-Intravitreal Injection Pain
2-hour Post-Intravitreal Injection
Post-Intravitreal Injection Pain
1-day Post-Intravitreal Injection
Post-Intravitreal Injection Pain
1-week Post-Intravitreal Injection
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded placebo-controlled design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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).', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}
Updated at
2024-01-22
1 organization
1 product
1 indication
Indication
Age-related macular degeneration