Light-Adaptive Contact Lenses for Visual Impairment

Overseen By Samantha McIntosh, OD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Disqualifiers: Pregnancy, Recent ocular surgery, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment.

Do I need to stop taking 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 the treatment Acuvue Oasys with Transitions Light Intelligent Technology for visual impairment?

Research shows that Acuvue Oasys lenses, made from senofilcon A, are well-tolerated by the eyes over long-term use and can improve comfort and visual acuity in various conditions. This suggests that the lenses may be effective for visual impairment by providing comfort and stable vision. ^{1 2 3 4 5}

Is it safe to use light-adaptive contact lenses like Acuvue Oasys with Transitions?

Research on similar contact lenses, like Acuvue Oasys with Hydraclear Plus, shows they are generally safe for long-term use, with good tolerance by eye tissues. ^{1 3 5 6 7}

What makes Acuvue Oasys with Transitions unique for visual impairment?

Acuvue Oasys with Transitions is unique because it combines contact lenses with light-adaptive technology, allowing the lenses to automatically adjust to changing light conditions, which is not a feature found in standard contact lenses. ^{1 3 5 6 8}

Research Team

So Yeon Lee, OD

Principal Investigator

Nova Southeastern University

Eligibility Criteria

This trial is for individuals who experience glare and light sensitivity due to conditions like Stargardt's, Cone dystrophy, or Albinism. Participants must be impacted in their daily activities by these issues, able to wear contact lenses, give informed consent, and understand English. Pregnant individuals or those with recent eye infections or surgeries are excluded.

Inclusion Criteria

Willing and able to wear the contact lenses as instructed

I experience glare and light sensitivity that affects my daily activities.

I have a diagnosed eye condition like Stargardt's or Retinitis Pigmentosa.

Exclusion Criteria

Are pregnant, nursing or planning to become pregnant during the course of the study

I have had eye problems or surgery in the last 3 months that prevent me from wearing contact lenses.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are fitted with Acuvue Oasys with Transitions contact lenses to assess improvement in glare, light sensitivity, and visual comfort

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including visual acuity and contrast sensitivity tests

6 weeks

1 visit (in-person)

Treatment Details

Interventions

• Acuvue Oasys with Transitions

Trial Overview The study is testing Acuvue Oasys with Transitions contact lenses to see if they can improve visual comfort by reducing glare and light sensitivity for people with visual impairments.

Participant Groups

Group I: Treatment group Experimental Treatment 1 Intervention

All participants will be fit with Acuvue Oasys with Transitions.

Acuvue Oasys with Transitions is already approved in United States, European Union for the following indications:

Approved in United States as Acuvue Oasys with Transitions for:

• Visual impairment
• Glare reduction
• Light sensitivity improvement

Approved in European Union as Acuvue Oasys with Transitions for:

• Visual impairment
• Glare reduction
• Light sensitivity improvement

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

American Academy of Optometry

Collaborator

Trials

6

Recruited

290+

Findings from Research

Over half of the 1,092 soft contact lens wearers reported issues such as dryness (23%), discomfort (13%), or uncomfortable wear for at least 2 hours (27%), indicating a high prevalence of problems among users.

Refitting 112 problem patients with senofilcon A silicone hydrogel lenses resulted in significant improvements: 75% experienced less dryness, 88% reported better comfort, and 76% had fewer uncomfortable hours of wear, demonstrating the efficacy of these lenses in addressing common discomfort issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of ocular surface symptoms, signs, and uncomfortable hours of wear in contact lens wearers: the effect of refitting with daily-wear silicone hydrogel lenses (senofilcon a). Riley, C., Young, G., Chalmers, R.[2007]

A novel technique using an inverted senofilcon A lens significantly improved visual acuity and comfort for a patient experiencing discomfort with conventional soft contact lenses after laser vision correction, achieving 6/6+ vision.

The patient reported a decrease in dry eye symptoms, as indicated by a reduction in the Dry Eye Questionnaire-8 score from 22 to 15, and was able to wear the lenses comfortably for 9 hours a day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inverted lens provides reverse geometry solution for post laser vision correction (LVC) corneas. Erdinest, N., London, N., Lavy, I., et al.[2022]

In a study involving 107 symptomatic contact lens wearers, switching to ACUVUE OASYS® 1-Day with HydraLuxe™ Technology significantly improved comfort scores after 2 weeks, with 75.7% of participants experiencing a clinically meaningful increase in comfort.

The same group of participants also reported a significant reduction in dryness and discomfort symptoms, with 82.2% showing a clinically meaningful decrease in discomfort scores, and 57% becoming asymptomatic after 2 weeks of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of daily disposable senofilcon A contact lenses in a symptomatic population. Bishop, MJ., Sun, CK., Coles-Brennan, C., et al.[2022]

The KeraSoft IC lens was successfully used in a 30-year-old woman with bilateral corneal ectasia, significantly improving her visual acuity and comfort during physical activities.

This case demonstrates the effectiveness of specialty contact lenses in managing irregular corneas, particularly after surgical interventions like penetrating keratoplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft Contact Lens Optimizes Visual Goals for a Patient with Keratoectasia. Lagina, AL.[2018]

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]

A 2-year study demonstrated that Acuvue® Oasys™ contact lenses made from senofilcon A silicone hydrogel provide excellent ocular tissue tolerance during long-term daily wear.

The lenses showed high biocompatibility, indicating they are safe and comfortable for users, especially those who previously wore soft contact lenses successfully.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of the daily wear of senofilcon A silicone hydrogel contact lenses on corneal and conjunctival tissues. Guillon, M., Maïssa, C.[2010]

In a study involving 48 patients over 2 weeks, the 1-Day Acuvue contact lens was found to be less preferred compared to Medalist, Surevue, and Biomedics 55 lenses among non-allergic patients, highlighting the importance of lens comfort and handling in overall preference.

For patients with allergies, the 1-Day Acuvue lens showed no significant preference compared to other lenses, indicating that comfort is the primary factor influencing their choice, while corneal swelling was similar between the 1-Day Acuvue and Medalist lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and overnight corneal swell comparison of the 1-Day Acuvue lens versus the Medalist, Surevue, Biomedics, and Acuvue lenses. Bucci, FA., Myers, PJ., Evans, RE., et al.[2017]

In vitro studies showed that common ophthalmic solutions significantly absorbed into Acuvue Oasys silicone hydrogel lenses, indicating potential concerns about drug and preservative accumulation.

However, in vivo results revealed that no active ingredients or preservatives were found on the lenses worn by patients, suggesting that the discomfort some users experience is not due to buildup on the lenses, which supports the safe use of these bandage lenses with eye drops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro and in vivo effects of ophthalmic solutions on silicone hydrogel bandage lens material Senofilcon A. Erdal, NB., Adolfsson, KH., De Lima, S., et al.[2019]

References

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

Prevalence of ocular surface symptoms, signs, and uncomfortable hours of wear in contact lens wearers: the effect of refitting with daily-wear silicone hydrogel lenses (senofilcon a). [2007]

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

Inverted lens provides reverse geometry solution for post laser vision correction (LVC) corneas. [2022]

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

Evaluation of daily disposable senofilcon A contact lenses in a symptomatic population. [2022]

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

Soft Contact Lens Optimizes Visual Goals for a Patient with Keratoectasia. [2018]

5. 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]

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

Long-term effects of the daily wear of senofilcon A silicone hydrogel contact lenses on corneal and conjunctival tissues. [2010]

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

Clinical and overnight corneal swell comparison of the 1-Day Acuvue lens versus the Medalist, Surevue, Biomedics, and Acuvue lenses. [2017]

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

In vitro and in vivo effects of ophthalmic solutions on silicone hydrogel bandage lens material Senofilcon A. [2019]