Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity
2 other identifiers
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2025
CompletedFirst Posted
Study publicly available on registry
October 31, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 27, 2026
April 1, 2026
8 months
October 29, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 1 week
Study Arms (2)
Participants with concussion and light sensitivity fit with broad band (clear) contact lens
ACTIVE COMPARATORUPSIS-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 COMPARATORUPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in narrow wavelength (tinted) contact lenses.
Interventions
Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).
Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAB Eye Care
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Candice I Turner, OD
University of Alabama at Birmingham School of Optometry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 29, 2025
First Posted
October 31, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04