Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity

NCT07223086 — Not applicable, Recruiting, 60 participants, University of Alabama at Birmingham

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Registry	NCT07223086
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	University of Alabama at Birmingham (Other)
Conditions	Concussion, Mild, Photophobia, Contact Lens
Interventions	Narrow band (tinted) contact lenses, broad band (clear) contact lenses (Device)
Dates	start 2026-05-08, primary completion 2026-12-31 (estimated), completion 2027-04-01 (estimated), first posted 2025-10-31, last updated 2026-06-11
Locations	1 site in United States

-Summary

The purpose of this study is to gather pilot data on the effectiveness of daily disposable tinted contact lenses in reducing photophobia (light sensitivity) following a concussion, with the goal of facilitating the return to work or school.

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+Arms and interventions

Arm	Type	Interventions	Description
Participants with concussion and light sensitivity fit with broad band (clear) contact lens	Active comparator	Device: broad band (clear) contact lenses	UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in broad band (clear) contact lenses.
Participants with concussion and light sensitivity fit with narrow band (tinted) contact lens	Active comparator	Device: Narrow band (tinted) contact lenses	UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in narrow wavelength (tinted) contact lenses.

Narrow band (tinted) contact lenses (Device), also known as Altius contact lenses: Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).
broad band (clear) contact lenses (Device), also known as BioTrue One Day, Infuse daily disposable contact lenses, Clariti 1 Day clear contact lenses: Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).

+Outcome measures

Primary outcomes

Number of participants that improved symptoms of light sensitivity with narrow band (tinted) contact lenses [Baseline, 1 week]: Improvement in the Utah Photophobia Symptom Impact Scale version 2 (UPSIS-2) on a scale of 15-60. Anything over 26 is considered significant.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* diagnosed mild traumatic brain injury (concussion)
* age 18 or older
* Within 24 months of initial injury
* experiencing symptoms of photophobia (light sensitivity), increased photophobia since the injury, or no symptoms of photophobia

Exclusion Criteria:

* moderate or severe concussion
* active infection or inflammation that contradicts the use of soft contact lenses
* subjects unable to safely perform insertion and removal of the contact lenses

+Locations (1)

Facility	City	Country	Status
UAB Eye Care	Birmingham, Alabama	United States	Recruiting

+Investigators

Candice I Turner, OD, Principal investigator, University of Alabama at Birmingham School of Optometry