Comparing the effectiveness of spectacles and contact lenses for light sensitivity

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

This study is testing whether tinted contact lenses can help people with migraines feel less sensitive to light compared to tinted glasses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Oklahoma (Academic / other)
• Locations: 1 site (Oklahoma City, Oklahoma)
• Trial ID: NCT06905912 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Altius tinted contact lenses compared to FL-41 tinted spectacles in reducing photophobia, particularly in individuals who suffer from migraines. The research is based on the premise that contact lenses, which filter out a higher percentage of blue light and cover the cornea directly, may provide greater relief from light sensitivity than spectacles. Two hundred participants who have previously worn FL-41 spectacles will be recruited, and their responses to both interventions will be assessed. The study aims to determine which option offers better symptom relief for patients experiencing light sensitivity.

Who should consider this trial

Good fit: Ideal candidates are individuals who have worn FL-41 tinted spectacles for at least one month and have light sensitivity due to migraines.

Not a fit: Patients with infectious or progressive ocular diseases will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a more effective option for managing photophobia associated with migraines.

How similar studies have performed: Previous studies have shown that tinted lenses can be effective in reducing migraine symptoms, but the specific comparison of contact lenses to spectacles in this context is novel.

Eligibility criteria

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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Where this trial is running

Oklahoma City, Oklahoma

• Dean McGee Eye Institute — Oklahoma City, Oklahoma, United States (Recruiting)

Study contacts

• Study coordinator: Jeffrey S Samples, AS

Conditions Photophobia; Light Sensitivity