Comparison Between Spectacles and Contact Lenses

NCT06905912 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 17528
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Photophobia

Keywords

Photophobia; Light Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• Evaluating FL-41 Tinted Spectacles

  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

  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

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

• Evaluating Altius Amber Tinted Contacts

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

Study Arms (1)

Altius Tinted Contact Lenses

EXPERIMENTAL

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

Interventions

Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses DEVICE

Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses

Altius Tinted Contact Lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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. \-

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Oklahoma: lead
• Dean A. McGee Eye Institute: collaborator

Study Sites (1)

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (3)

• Blackburn MK, Lamb RD, Digre KB, Smith AG, Warner JE, McClane RW, Nandedkar SD, Langeberg WJ, Holubkov R, Katz BJ. FL-41 tint improves blink frequency, light sensitivity, and functional limitations in patients with benign essential blepharospasm. Ophthalmology. 2009 May;116(5):997-1001. doi: 10.1016/j.ophtha.2008.12.031.

  PMID: 19410958 BACKGROUND

• Burstein R, Noseda R, Fulton AB. Neurobiology of Photophobia. J Neuroophthalmol. 2019 Mar;39(1):94-102. doi: 10.1097/WNO.0000000000000766.

  PMID: 30762717 BACKGROUND

• Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. eCollection 2021.

  PMID: 35281991 BACKGROUND

MeSH Terms

Conditions

Photophobia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Melson, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey S Samples, AS

CONTACT

706-662-7878; scott-samples@dmei.org

Andrew Melson, MD

CONTACT

405-271-6084; andrew-melson@dmei.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This trial will not be blinded as the vivid coloration (or lack thereof) of the lens is obvious as to which is worn.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: April 2, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)