Spectacles vs Contact Lenses for Photophobia

Overseen By Andrew Melson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Infectious ocular disease, Progressive ocular disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 30 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of contact lenses, Altius Tinted and Biomedics55 Premier, might assist people with photophobia (light sensitivity), which often affects those with migraines. The goal is to determine if these lenses can provide relief for individuals who typically rely on special tinted glasses to manage their symptoms. Candidates include those who have used FL-41 tinted glasses for at least a month and can tolerate contact lenses. The study aims to improve light sensitivity management, potentially enabling participants to engage more in daily activities without discomfort. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance daily life for those with light sensitivity.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Altius Tinted Contact Lenses are generally well-tolerated. In one study, these lenses significantly reduced light sensitivity, with patient scores dropping from 8.86 to 2.58. Most users, about 84%, felt more comfortable using screens during migraine episodes, and 80% reported less severe light sensitivity.

Although direct safety data is lacking, the lenses' ability to block 99% of blue light suggests promise in reducing light sensitivity. No significant reports of side effects have emerged, indicating these lenses could be a safe option for managing light sensitivity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Altius Tinted Contact Lenses for photophobia because they offer a unique approach by incorporating tinted lenses to reduce light sensitivity. Unlike standard options like sunglasses or regular contact lenses, these lenses come with specific tints designed to filter out certain wavelengths of light, potentially offering more precise relief from discomfort. This tailored light-filtering capability could provide faster and more effective symptom management, making daily activities much more comfortable for those dealing with photophobia.

What evidence suggests that this trial's treatments could be effective for photophobia?

Research shows that Altius Tinted Contact Lenses, which participants in this trial may receive, can help reduce light sensitivity, also known as photophobia. These lenses block 99% of blue light, which can trigger photophobia. Studies have found that tinted lenses can greatly ease light sensitivity symptoms. Sitting directly on the eye, these lenses might offer better protection than glasses. This could be especially useful for people who experience migraines or have other conditions worsened by bright light. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with light sensitivity or photophobia who have good vision (at least 20/30) with contact lenses and can handle them without professional help. They should not have any infectious eye diseases and must have used FL-41 tinted spectacles for at least a month.

Inclusion Criteria

I do not have any eye infections or worsening eye conditions.

Subjects must have at least 20/30 distance visual acuity in each eye while wearing the contact lenses. Altius lenses are currently available in spherical powers from plano to -6.00

Subjects must demonstrate the ability to insert and remove contact lenses. Assistance from friends and family is acceptable

Exclusion Criteria

Subjects not meeting all of the above criteria will be excluded from participating in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear FL-41 Tinted Spectacles, Biomedics 55 Premier Contacts, and Altius Tinted Contacts to evaluate their effect on photophobia

30 days

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Altius Tinted Contact Lenses
• Biomedics55 Premier contact lenses

Trial Overview The study compares two types of contact lenses, Biomedics55 Premier and Altius Tinted Contact Lenses, to see which one better helps people manage light sensitivity that often leads to migraines.

How Is the Trial Designed?

Group I: Altius Tinted Contact Lenses Experimental Treatment 1 Intervention

Subjects will be asked to wear either of the two tints available for ten days

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Dean A. McGee Eye Institute

Collaborator

Trials

1

Recruited

4,500+

Published Research Related to This Trial

A 2-year study demonstrated that Acuvue® Oasys™ contact lenses made from senofilcon A silicone hydrogel provide excellent ocular tissue tolerance during long-term extended wear, specifically when worn for up to 6 nights without removal.

The study showed that these lenses maintain good biocompatibility, making them a safe option for individuals who are accustomed to wearing daily soft contact lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of the extended wear of senofilcon A silicone hydrogel contact lenses on ocular tissues. Guillon, M., Maïssa, C.[2016]

Extended-wear soft contact lenses are associated with a significantly higher risk of complications compared to gas-permeable hard lenses, with a relative risk of 2.7, indicating they may not be the safest option for new users.

Daily wear soft contact lenses also present risks, particularly for users with toxic or hypersensitivity disorders, where the relative risk is as high as 5.9, suggesting careful selection and monitoring of lens types is crucial for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonulcerative complications of contact lens wear. Relative risks for different lens types. Stapleton, F., Dart, J., Minassian, D.[2019]

In a study involving 8 myopic participants, bifocal contact lenses (MCL) showed a general decrease in visual acuity (VA) and contrast sensitivity (CS) compared to single vision lenses (SV), indicating they may not be as effective for all gaze positions.

The defocus incorporated multiple segments (DIMS) lenses performed similarly to SV lenses at straight gaze (0°), but both DIMS and MCL resulted in decreased VA and CS at nasal and temporal gaze, suggesting that while DIMS can be effective, they may not provide a significant advantage over traditional lenses in all viewing conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. Kaymak, H., Neller, K., Schütz, S., et al.[2022]

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. altiusvision.com altiusvision.com/wp-content/uploads/Photosensitivity-and-ALTIUS-January-2024.pdf

1 Use of Performance-Tinted Contact Lenses in Patients ... Previous research also has demonstrated that photophobia symptoms can be relieved by blue-blocking lenses,4-7 including lenses with FL-41 or similar tint.2 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06905912

Comparison Between Spectacles and Contact Lenses Altius tinted contact lenses filter out 99% of blue light and therefore should be more effective at reducing photophobia. Since the contact lens has direct ...

4. withpower.com withpower.com/trial/phase-photophobia-11-2024-6b3fe

Spectacles vs Contact Lenses for Photophobia Altius Tinted Contact Lenses are unique because they are specifically designed to reduce light sensitivity (photophobia) by using tinted lenses, which can help ...

5. trial.medpath.com trial.medpath.com/clinical-trial/b0e3422fc71c24e9/nct06905912-fl41-spectacles-biomedics55-altius-contact-lenses-photophobia

Comparison Between Spectacles and Contact Lenses | MedPath Altius tinted contact lenses filter out 99% of blue light and therefore should be more effective at reducing photophobia. Since the contact lens has direct ...

6. altiusvision.com altiusvision.com/ovdra/

New clinical data on photophobia management presented ... The data demonstrated a statistically significant reduction in light sensitivity symptoms—average patient scores dropped from 8.86 to 2.58 after ...

7. meddatax.com meddatax.com/clinical-trials/NCT07223086

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) ...

8. linkedin.com linkedin.com/posts/altiusvision_migrainerelief-digitaleyestrain-lightsensitivity-activity-7371917216449048576-bcOo

ALTIUS lenses improve screen tolerance and light sensitivity for ... In an internal patient survey, 84% of users reported improved screen tolerance during migraine episodes, while 80% experienced reduced severity of light ...