Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity

ConditionsConcussion, Mild Photophobia Contact Lens

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Narrow band (tinted) contact lenses
Device
Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).
broad band (clear) contact lenses
Device
Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Participants with concussion and light sensitivity fit with broad band (clear) contact lensActive comparator 1 intervention

Group B: Participants with concussion and light sensitivity fit with narrow band (tinted) contact lensActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number of participants that improved symptoms of light sensitivity with narrow band (tinted) contact lenses

Improvement in the Utah Photophobia Symptom Impact Scale version 2 (UPSIS-2) on a scale of 15-60. Anything over 26 is considered significant.

Time frame

Baseline, 1 week

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

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