Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity The Purpose of This Study is to Gather Pilot Data on the Effectiveness of Daily Disposable Tinted Contact Lenses in Reducing Light Sensitivity Following a Concussion in Patient 18 or Older.

NCT ID: NCT07223086

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2027-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Concussion, Mild Photophobia Contact Lens

Keywords

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Mild concussion tinted contact lenses light sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with concussion and light sensitivity

UPSIS-2 scale 15-60, eligible particpants score greater than or equal to 26

Group Type ACTIVE_COMPARATOR

Narrow band (tinted) contact lenses

Intervention Type DEVICE

Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).

broad band (clear) contact lenses

Intervention Type DEVICE

Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).

Interventions

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Narrow band (tinted) contact lenses

Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).

Intervention Type DEVICE

broad band (clear) contact lenses

Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).

Intervention Type DEVICE

Other Intervention Names

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Altius contact lenses BioTrue One Day Infuse daily disposable contact lenses Clariti 1 Day clear contact lenses

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Candice Turner

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Candice I Turner, OD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham School of Optometry

Locations

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UAB Eye Care

Birmingham, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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Candice I Turner, OD

Role: CONTACT

Phone: (205)934-0997

Email: [email protected]

Katherine K Weise, OD

Role: CONTACT

Phone: (205) 934-6758

Email: [email protected]

Facility Contacts

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Candice I Turner, OD

Role: primary

Katherine K Weise, OD

Role: backup

Other Identifiers

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Faculty development grant

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300015049

Identifier Type: -

Identifier Source: org_study_id