An interventional study of Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses in Photophobia, sponsored by University of Oklahoma. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Supportive care
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.
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.
43 studies on the registry are indexed under Photophobia; 13 are open to participants now.
This study's planned enrollment of 200 is above the median of 43 across 36 interventional studies indexed under Photophobia.
Browse Photophobia studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Two hundred voluntary subjects will be recruited by researching those who have purchased FL-41 tinted spectacles from the Dean McGee Eye Institute Optical Department. If this does not recruit enough subjects then subject referrals will be solicited from the patient population of the Dean McGee Eye Institute and/or neurology clinics throughout the Oklahoma City metro area.
Subjects must meet the following criteria in order to participate in this study:
Subjects not meeting all of the above criteria will be excluded from participating in this study.
Early Termination:
If a subject feels their photophobia increases to an intolerable level, they can stop wearing that contact lens type and switch to the other the next day or terminate participation in the study. If this occurs, the data from those subjects will still be included in the study data analysis.
If a subject or physician feel that the health of their cornea is at risk, the subject will cease wearing all contact lenses and seek medical care from the Dean McGee Eye Institute.
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Subjects will be asked to wear either of the two tints available for ten days
Device: Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses
Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses
Comparing FL-41 Tinted Eyeglasses, Biomedics 55 Premier, and Altius Grey-Green Tinted Contacts
questionnaires - scale of 1 to 10 - no light sensitivity and 10 extreme light sensitivity
Time frame: baseline, after 10 days of wearing Biomedics 22 Premier contacts, and after 10 days of wearing Altius colored contacts.
Evaluating FL-41 Tinted Spectacles
questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Time frame: immediately after subject finished at least 30 days of wearing the spectacles but before wearing the Biomedics 55 Premier Contacts
Evaluating Biomedics 55 Premier Contacts
questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Time frame: immediately after subject finished 10 days of wearing the Biomedics 55 premier contact lenses but before wearing the Altius tinted Contacts
Evaluating Altius Grey-Green Tinted Contacts
questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Time frame: immediately after subject finished 10 days of wearing the grey-green tinted contact lenses
Evaluating Altius Amber Tinted Contacts
questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity
Time frame: immediately after subject finished 10 days of wearing the amber tinted contacts
Plan to share: No
Start is estimated for Jul 2026; primary completion for Dec 2027, 17 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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