Cannabinoid vs Opioid for Photorefractive Keratectomy Pain Control

NCT05477875 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB202201660 -A
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the cannabinoid or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.

Conditions

Photorefractive Keratectomy; Myopia; Hyperopia

Outcome Measures

Primary Outcomes (2)

• Pain as Recorded by the FACES Scale (Maximum) After First Surgery

  The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"

  1 week after first surgery

• Pain as Recorded by the FACES Scale (Maximum) After Second Surgery

  The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"

  1 week after second surgery

Secondary Outcomes (5)

• Uncorrected Visual Acuity of First Eye Surgery

  3 months after first surgery

• PROWL-SS

  3 month

• Quality of Life Refractive Correction Survey

  3 months

• Ocular Discomfort Questionnaire

  3 months

• Uncorrected Visual Acuity of Second Eye Surgery

  3 months after second surgery

Study Arms (2)

Oral cannabinoid

EXPERIMENTAL

Oral cannabinoid

Drug: oral cannabinoid

Oral codeine/acetaminophen

ACTIVE COMPARATOR

Oral codeine-acetaminophen for controlling pain

Combination Product: oral codeine/acetaminophen

Interventions

oral cannabinoid DRUG

dronabinol

Also known as: dronabinol

Oral cannabinoid

oral codeine/acetaminophen COMBINATION_PRODUCT

10 tablets of acetaminophen-codeine combination (300-30mg) without refills.

Oral codeine/acetaminophen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults older than 18 years with refractive stability for 1 year electing to have PRK surgery
• Consenting to participate

You may not qualify if:

• Patients not candidates for PRK will be excluded from the study.
• Patients taking other pain medications for concomitant medical conditions including, but not limited to tricyclic antidepressants, gabapentin and tramadol will be excluded from the study.
• Patients completing follow up appointments at anywhere other than UF Health Ophthalmology clinic at the Oaks will not be enrolled in the study.
• Patients who are pregnant or nursing are not eligible for PRK, and such patients are not eligible to enroll in this study. Female patients of child-bearing age will be pregnancy tested before surgery and study enrollment.
• Patients will be specifically counseled, and it will be noted in the written informed consent that use of the cannabinoid product may result in a positive THC urinalysis screening test so they may self-exclude if such a situation could cause social and/or employment conflict.

Sponsors & Collaborators

• University of Florida: lead
• Consortium for Medical Marijuana Clinical Outcomes Research: collaborator

Study Sites (1)

University of Florida Oaks Eye Center

Gainesville, Florida, 32605, United States

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Interventions

Cannabinoids; Dronabinol; acetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

This study could not separate the effects of long-term vision quality of life outcomes between drugs, although these secondary outcomes are only for safety monitoring and not for comparing drug effects.

Results Point of Contact

• Title: Yujia Zhou
• Organization: University of Florida Oaks Eye Center

yzhou1996@ufl.edu

3522652020

Study Officials

• W Steigleman, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 28, 2022
• Study Start: February 1, 2024
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)