NCT06905912

Comparison Between Spectacles and Contact Lenses

Comparison Between FL41 Tinted Spectacles, Biomedics55 Premier Contact Lenses, and Altius Tinted Contact Lenses on Photophobia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Many people suffer from migraine headaches, some more so than others and a common trigger/complaint is light sensitivity, or photophobia1. Some will go to great lengths to avoid light: a dark room with sunglasses on and blankets over the windows, often missing work/school/social activities, etc. Several ocular conditions are accompanied by photophobia, ranging from mild to debilitating.

Detailed description

Burstein et al. describe a shared neuronal pathway between processing light and migraine signals2. Vessels in the dura mater, which are stimulated during migraines, provide input to the Trigeminal Ganglion (TG), which travels to spinal nuclei, which have connections that synapse in the Lateral Posterior Nucleus (LPN). Some intrinsically photosensitive retinal ganglion cells (ipRGC) also synapse through the LPN. The ipRGC are stimulated by light spectra, such as blue light. The crosstalk between the synapses of the ipRGC and pathways from the dura mater vessels causes an overwhelming number of signals that can cause symptoms ranging from cognitive, visual, motor, olfactory, or auditory disfunctions. Thus, it seems reasonable that a reduction in the amount of light stimulation will help alleviate the overload of signals during a migraine, which will decrease the intensity. FL-41 glasses filter out approximately 50% of blue light and have been shown effective for migraine reduction3. Altius tinted contact lenses filter out 99% of blue light and therefore should be more effective at reducing photophobia. Since the contact lens has direct contact with and coverage of the cornea, no unfiltered stray light is able to enter the eye thus enhancing its efficacy.

Conditions

• Photophobia

Interventions

Type	Name	Description
DEVICE	Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses	Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-04-02
• Last updated: 2025-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study