Concussion, MildNCT07223086
Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity
A study testing Narrow band (tinted) contact lenses and broad band (clear) contact lenses in people with Concussion, Mild and Photophobia, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concussion, Mild, Photophobia, Contact Lens
- What is being tested?
- Narrow band (tinted) contact lenses and broad band (clear) contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB Eye Care
Birmingham, Alabama, 35294
Candice I Turner, OD, (205)934-0997, citurner@uab.edu
Katherine K Weise, OD, (205) 934-6758, kweise@uab.edu
About this study
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.
- Conditions
- Concussion, Mild, Photophobia, Contact Lens
- Being tested
- Narrow band (tinted) contact lenses, broad band (clear) contact lenses
- Keywords
- Mild concussion, tinted contact lenses, light sensitivity
- Medical subject headings
- Brain Concussion, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band (tinted) contact lensesDevice
Also called Altius contact lenses
Participants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey).
broad band (clear) contact lensesDevice
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| Participants with concussion and light sensitivity fit with broad band (clear) contact lens | Active comparator | UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in broad band (clear) contact lenses. Receives: Device: broad band (clear) contact lenses |
| Participants with concussion and light sensitivity fit with narrow band (tinted) contact lens | Active comparator | UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in narrow wavelength (tinted) contact lenses. Receives: Device: Narrow band (tinted) contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start8 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candice Turner, University of Alabama at Birmingham
- Investigators
- Candice I Turner, OD, Principal investigator, University of Alabama at Birmingham School of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223086
- Sponsor's protocol ID
- IRB-300015049
- Other IDs
- Faculty development grant
- Status last verified
- Jun 2026
- First submitted
- 29 Oct 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tinted Contact Lenses for Concussion-Related Light Sensitivity
- ClinicalTrials.gov ID
- NCT07223086
- Acronym / sponsor ID
- IRB-300015049
- Conditions
- Concussion, Mild, Photophobia, Contact Lens
- Keywords
- Mild concussion, tinted contact lenses, light sensitivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with concussion and light sensitivity fit with broad band (clear) contact lens | Active comparator | Device: broad band (clear) contact lensesUPSIS-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 lensesUPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in narrow wavelength (tinted) contact lenses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrow band (tinted) contact lensesAlso: Altius contact lensesParticipants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey). | Device | Participants with concussion and light sensitivity fit with narrow band (tinted) contact lens |
| broad band (clear) contact lensesAlso: BioTrue One Day, Infuse daily disposable contact lenses, Clariti 1 Day clear contact lensesParticipants will receive these contacts based on the results of the Utah Photophobia Symptom Impact Scale (survey). | Device | Participants with concussion and light sensitivity fit with broad band (clear) contact lens |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Candice I Turner, OD principal investigator
University of Alabama at Birmingham School of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow band (tinted) contact lenses and broad band (clear) contact lenses in people with Concussion, Mild and Photophobia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candice I Turner, OD ((205)934-0997, citurner@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that improved symptoms of light sensitivity with narrow band (tinted) contact lenses (time frame: Baseline, 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.