NCT07223086

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress2%
May 2026Apr 2027

First Submitted

Initial submission to the registry

October 29, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

October 29, 2025

Last Update Submit

April 24, 2026

Conditions

Keywords

Mild concussiontinted contact lenseslight sensitivity

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 COMPARATOR

UPSIS-2 scale 15-60, eligible participants score greater than or equal to 26 are fit in broad band (clear) contact lenses.

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.

Device: Narrow band (tinted) contact lenses

Interventions

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

Also known as: Altius contact lenses
Participants with concussion and light sensitivity fit with narrow band (tinted) contact lens

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

Also known as: BioTrue One Day, Infuse daily disposable contact lenses, Clariti 1 Day clear contact lenses
Participants with concussion and light sensitivity fit with broad band (clear) contact lens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Brain ConcussionPhotophobia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Candice I Turner, OD

    University of Alabama at Birmingham School of Optometry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Candice I Turner, OD

CONTACT

Katherine K Weise, OD

CONTACT

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

Locations