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NCT Number: NCT06905912

Comparison Between Spectacles and Contact Lenses

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location contact

Andrew Melson, MD

CONTACT

[email protected]

405-271-1091 ext. 11091

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 must have worn FL-41 tinted spectacles for at least one month prior to participating in this study.
  • Subjects must have at least 20/30 distance visual acuity in each eye while wearing the contact lenses. Altius lenses are currently available in spherical powers from plano to -6.00.
  • Subjects must demonstrate the ability to insert and remove contact lenses. Assistance from friends and family is acceptable.
  • Subjects must not have an infectious or progressive ocular disease.

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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Treatment and study plan

Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses

Device

Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses

Primary outcomes

  1. Comparing FL-41 Tinted Eyeglasses, Biomedics 55 Premier, and Altius Grey-Green Tinted Contacts

    Time frame: baseline, after 10 days of wearing Biomedics 22 Premier contacts, and after 10 days of wearing Altius colored contacts.

    questionnaires - scale of 1 to 10 - no light sensitivity and 10 extreme light sensitivity

Secondary outcomes

  1. Evaluating FL-41 Tinted Spectacles

    Time frame: immediately after subject finished at least 30 days of wearing the spectacles but before wearing the Biomedics 55 Premier Contacts

    questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity

  2. Evaluating Biomedics 55 Premier Contacts

    Time frame: immediately after subject finished 10 days of wearing the Biomedics 55 premier contact lenses but before wearing the Altius tinted Contacts

    questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity

  3. Evaluating Altius Grey-Green Tinted Contacts

    Time frame: immediately after subject finished 10 days of wearing the grey-green tinted contact lenses

    questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity

  4. Evaluating Altius Amber Tinted Contacts

    Time frame: immediately after subject finished 10 days of wearing the amber tinted contacts

    questionnaire - scale 1-10 :1-no light sensitivity and 10 extreme light sensitivity

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Melson, MD

CONTACT

[email protected]

405-271-6084

Jeffrey S Samples, AS

CONTACT

[email protected]

706-662-7878

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Dean A. McGee Eye Institute

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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