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

Trial Summary

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.

What data supports the effectiveness of Altius Tinted Contact Lenses for treating photophobia?

Research on photochromic contact lenses, which change tint in response to light, shows they can improve visual performance and satisfaction in various lighting conditions, suggesting potential benefits for people with light sensitivity (photophobia). ^{1 2 3 4 5}

Are tinted contact lenses safe for reducing light sensitivity?

Tinted contact lenses have been studied for their safety and comfort. One study found that antimicrobial contact lenses were biocompatible and comfortable during extended wear, showing no significant adverse effects on the eyes. However, another study noted that different types of soft contact lenses can lead to dissatisfaction and adverse events if substituted without proper fitting. ^{6 7 8 9 10}

How do Altius Tinted Contact Lenses differ from other treatments 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 filter out certain wavelengths of light. This approach is different from standard clear lenses or spectacles, which do not offer this targeted light filtering capability. ^{11 12 13 14 15}

What is the purpose of this trial?

Many people suffer from migraine headaches, some more so than others and a common trigger/complaint is light sensitivity, or photophobia1. Some will go to great lengths to avoid light: a dark room with sunglasses on and blankets over the windows, often missing work/school/social activities, etc. Several ocular conditions are accompanied by photophobia, ranging from mild to debilitating.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of Photochromic Contact Lens Wear on Indoor Visual Performance and Patient Satisfaction. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Wavelength Characteristics and Visual Function of Photochromic Contact Lenses in Indoor and Outdoor Conditions. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Lens fitting and subjective acceptance of senofilcon A with photochromic additive on a neophyte population. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Clinical performance and Willingness To Pay for soft toric contact lenses in low and moderate astigmats. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Vision tests on spectacle lenses and contact lenses for optical myopia correction: a pilot study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

All soft contact lenses are not created equal. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Tinted hydrogel lenses: an assessment of glare sensitivity reduction. [2004]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Biocompatibility and Comfort during Extended Wear of Mel4 Peptide-Coated Antimicrobial Contact Lenses. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events during 2 years of daily wear of silicone hydrogels in children. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Nonulcerative complications of contact lens wear. Relative risks for different lens types. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Objective and subjective evaluation of the performance of medical contact lenses fitted using a contact lens selection algorithm. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical comparison of OPTI-FREE EXPRESS and ReNu MultiPLUS multipurpose lens care solutions. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

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

14. United States pubmed.ncbi.nlm.nih.gov

Clinical performance of two opaque, tinted soft contact lenses. [2006]

15. United States pubmed.ncbi.nlm.nih.gov

The effect of the ChromaGen contact lens system on visual performance. [2021]