Comparison Between Spectacles and Contact Lenses

NCT ID: NCT06905912

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2025-09-01

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.

Detailed Description

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.

Conditions

Photophobia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Altius Tinted Contact Lenses

Subjects will be asked to wear either of the two tints available for ten days

Group Type: EXPERIMENTAL

Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses

Intervention Type: DEVICE

Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses

Interventions

Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses

Biomedics55 Premier contact lenses, and Altius Tinted Contact Lenses

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dean A. McGee Eye Institute

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dean McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeffrey S Samples, AS

Role: CONTACT

scott-samples@dmei.org

7066627878

Andrew Melson, MD

Role: CONTACT

andrew-melson@dmei.org

4052716084

Facility Contacts

Andrew Melson, MD

Role: primary

Andrew-Melson@dmei.org

405-271-1091 ext. 11091

References

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.

Reference Type: BACKGROUND

PMID: 19410958 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 30762717 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35281991 (View on PubMed)

Other Identifiers

17528

Identifier Type: -

Identifier Source: org_study_id