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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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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Locations
United States
Oklahoma
Dean McGee Eye Institute
RECRUITING
Oklahoma City
Contact Information
Primary
Jeffrey S Samples, AS
scott-samples@dmei.org
7066627878
Backup
Andrew Melson, MD
andrew-melson@dmei.org
4052716084
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 200
Treatments
Experimental: Altius Tinted Contact Lenses
Subjects will be asked to wear either of the two tints available for ten days
Related Therapeutic Areas
Sponsors
Collaborators: Dean A. McGee Eye Institute
Leads: University of Oklahoma

This content was sourced from clinicaltrials.gov