Tinted Contact Lenses for Light Sensitivity

Overseen By Katherine K Weise, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Moderate/severe concussion, active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tinted contact lenses can ease light sensitivity after a concussion. The goal is to determine if these lenses can facilitate a return to work or school for those affected. The trial seeks individuals who have experienced a mild concussion in the past two years and are dealing with new or worsened light sensitivity since the injury. Participants are ineligible if they have moderate or severe concussions, eye issues that prevent lens use, or cannot handle contact lenses safely. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance daily life for those with post-concussion light sensitivity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these tinted contact lenses are safe for reducing light sensitivity?

Research has shown that tinted contact lenses are as safe and effective as other approved contact lenses for extended wear. Most people can use them without issues, and they do not cause more side effects than regular contact lenses. Common problems with any contact lenses, such as blurry vision, eye pain, or a sensation of something in the eye, are not specific to tinted lenses. Overall, safety research suggests that tinted lenses are a safe choice for those with light sensitivity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for light sensitivity, which often rely on medications or lifestyle adjustments, tinted contact lenses offer a non-invasive, immediate solution. These lenses work by selectively filtering out specific wavelengths of light, which can reduce discomfort and improve visual clarity without altering one's activities or environment. Researchers are excited because this approach directly targets the root cause of light sensitivity, potentially offering relief for those who experience this condition, especially after a concussion.

What evidence suggests that tinted contact lenses might be an effective treatment for light sensitivity following a concussion?

Research has shown that tinted contact lenses can reduce sensitivity to light, particularly for individuals experiencing ongoing eye pain or discomfort. In one study, 76% of participants with these issues reported significant improvement when using lenses with the FL-41 tint. This tint appears to calm specific nerve pathways that cause discomfort in bright light. Although not everyone experiences relief with these lenses, many do feel better. This trial will evaluate the effectiveness of tinted contact lenses for participants with concussion-related light sensitivity, suggesting they could be a promising way to manage symptoms and facilitate a return to daily activities. ^{1 5 6 7 8}

Who Is on the Research Team?

Candice I Turner, OD

Principal Investigator

University of Alabama at Birmingham School of Optometry

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 or older who are experiencing light sensitivity (photophobia) as a result of a concussion. Participants should require assistance to return to work or school due to their condition.

Inclusion Criteria

I have been diagnosed with a mild concussion.

I am 18 years old or older.

My injury occurred within the last 24 months.

Exclusion Criteria

Active infection or inflammation that contradicts the use of soft contact lenses

Subjects unable to safely perform insertion and removal of the contact lenses

I have had a moderate or severe concussion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use daily disposable tinted contact lenses to reduce light sensitivity

1 week

Baseline visit, 1 follow-up visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tinted Contact Lenses

Trial Overview The study is testing the effectiveness of daily disposable contact lenses in two varieties: one tinted (narrow band) and one clear (broad band), in reducing light sensitivity following a concussion.

How Is the Trial Designed?

Group I: Participants with concussion and light sensitivity Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223086

Use of Tinted Contact Lenses for Concussion-Related ... The purpose of this study is to gather pilot data on the effectiveness of daily disposable tinted contact lenses in reducing photophobia (light ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10939838/

FL-41 Tint Reduces Activation of Neural Pathways of ... In our study, 76% of patients with chronic ocular pain, DE symptoms, and photophobia reported clinically significant improvement in light-evoked ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002939423005123

FL-41 Tint Reduces Activation of Neural Pathways ... We demonstrated that FL-41 lenses can improve symptoms of photophobia in the majority but not all individuals with chronic ocular pain.

4. trial.medpath.com trial.medpath.com/clinical-trial/bb91db600f5e268e/nct07223086-tinted-contact-lenses-concussion-light-sensitivity

Use of Tinted Contact Lenses for Concussion-Related Light ... The purpose of this study is to gather pilot data on the effectiveness of daily disposable tinted contact lenses in reducing photophobia (light sensitivity) ...

5. researchgate.net researchgate.net/publication/6853710_Tinted_Contact_Lenses_as_an_Alternative_Management_for_Photophobia_in_Stationary_Cone_Dystrophies_in_Children

Tinted Contact Lenses as an Alternative Management for ... We assess the use of tinted contact lenses as an alternative management for the photophobia. Three children, aged 5 to 13, with cone dystrophies ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220007B.pdf

Summary of Safety and Effectiveness Data (SSED) • Photophobia (light sensitivity). • Burning ... contact lens is as safe and effective as other approved extended wear contact lenses.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10699545/

Impact of Tinted Lenses on Contrast Sensitivity, Color Vision ... Contrast sensitivity values were consistent at 2.00 logMAR, indicating good contrast sensitivity, irrespective of the presence of tinted lenses.

8. ophthalmologytimes.com ophthalmologytimes.com/view/prevent-blindness-promoting-contact-lens-safety

Prevent Blindness promoting contact lens safety Symptoms may include eye infection include blurry vision, pain in the eye, sensation of something in the eye, sensitivity to light ( ...