- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07223086
Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity
May 5, 2026 updated by: Candice Turner, University of Alabama at Birmingham
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Candice I Turner, OD
- Phone Number: (205)934-0997
- Email: citurner@uab.edu
Study Contact Backup
- Name: Katherine K Weise, OD
- Phone Number: (205) 934-6758
- Email: kweise@uab.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- UAB Eye Care
-
Contact:
- Candice I Turner, OD
- Phone Number: (205)934-0997
- Email: citurner@uab.edu
-
Contact:
- Katherine K Weise, OD
- Phone Number: (205) 934-6758
- Email: kweise@uab.edu
-
Principal Investigator:
- Candice I Turner, OD
-
Sub-Investigator:
- Katherine K Weise, OD
-
Sub-Investigator:
- Heidi Hernandez, OD
-
Sub-Investigator:
- Mallory Wright, OD
-
Sub-Investigator:
- Thom Houston, MD
-
Sub-Investigator:
- Mark Swanson, OD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Participants with concussion and light sensitivity fit with broad band (clear) contact lens
UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in broad band (clear) contact lenses.
|
Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).
Other Names:
|
|
Active Comparator: Participants with concussion and light sensitivity fit with narrow band (tinted) contact lens
UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in narrow wavelength (tinted) contact lenses.
|
Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants that improved symptoms of light sensitivity with narrow band (tinted) contact lenses
Time Frame: 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.
|
Baseline, 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Candice I Turner, OD, University of Alabama at Birmingham School of Optometry
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
October 29, 2025
First Submitted That Met QC Criteria
October 29, 2025
First Posted (Actual)
October 31, 2025
Study Record Updates
Last Update Posted (Actual)
May 8, 2026
Last Update Submitted That Met QC Criteria
May 5, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Injuries, Traumatic
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Eye Diseases
- Vision Disorders
- Sensation Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Brain Concussion
- Photophobia
- Equipment and Supplies
- Optical Devices
- Lenses
- Contact Lenses
Other Study ID Numbers
- IRB-300015049
- Faculty development grant (Other Grant/Funding Number: Faculty development grant)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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