Weekly Replacement Soft Contact Lenses for Astigmatism

Overseen By Emma Grant

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Eye lubricating drops

Disqualifiers: Ocular inflammation, Systemic conditions, Presbyopia, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests weekly replacement soft contact lenses for individuals with astigmatism, a condition that causes blurry or distorted vision. Researchers aim to understand the fit of these lenses, their impact on vision, and the wearing experience for those new to contacts. Participants will wear the lenses for about three weeks and provide feedback through surveys. The trial seeks adults with astigmatism who have never worn contact lenses and are not currently using eye drops. As an unphased trial, it offers participants the chance to contribute to advancements in vision care and enhance future contact lens options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using any medications that might affect the study, the investigator may ask you to stop.

What prior data suggests that these contact lenses are safe for people with astigmatism?

Research has shown that one-week replacement soft contact lenses are generally safe and comfortable for most people. For example, 91% of users reported the lenses were more comfortable than expected, and 98% found them easy to use.

As with all contact lenses, some warnings and precautions should be considered. These typically involve minor issues, such as dry eyes or slight discomfort, which are common with contact lens use. Overall, evidence suggests these lenses are a safe choice for people with astigmatism trying contact lenses for the first time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard contact lenses for astigmatism, which often require bi-weekly or monthly replacements, these weekly replacement soft contact lenses offer a more frequent refresh. This unique feature may improve comfort and vision clarity, as more frequent lens replacement can reduce protein buildup and dryness. Researchers are excited because this could lead to healthier eyes and enhance the overall wearing experience for individuals with astigmatism.

What evidence suggests that one week replacement soft contact lenses are effective for astigmatism?

Research shows that one-week replacement soft contact lenses, which participants in this trial will wear, can improve vision for people with astigmatism. Studies found these lenses work well for most: 93.72% success for high astigmatism, 90.78% for medium, and 88.89% for low astigmatism. Thus, individuals with varying levels of astigmatism can benefit from these lenses. Additionally, these lenses have improved vision in people with irregular astigmatism after eye surgery like LASIK. This evidence suggests the lenses are likely effective for most with astigmatism. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with astigmatism who have never worn contact lenses before. Participants will be asked to wear new soft contact lenses that are replaced weekly and must attend follow-up visits.

Inclusion Criteria

Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)

Willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear

Subjects must have 20/20 or better best corrected visual acuity

Exclusion Criteria

I have been diagnosed with dry eye disease.

Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein

Is pregnant or lactating or planning a pregnancy during enrollment in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are fit with one week planned-replacement soft contact lenses and wear them for approximately 3 weeks

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for vision and lens fit assessments and complete surveys about their wear experience

1 week

What Are the Treatments Tested in This Trial?

Interventions

• One week replacement soft contact lenses

Trial Overview

The study is testing the comfort and fit of a type of soft contact lens that is replaced every week. Participants will use these lenses for about 3 weeks, undergo vision assessments, and provide feedback on their experience.

How Is the Trial Designed?

Group I: Contact Lens Wear Experience Experimental Treatment 1 Intervention

One week replacement soft contact lenses will be worn for 3 weeks.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Alcon Research

Industry Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

In a study of 40 young adults with low astigmatism, soft toric contact lenses (TCL) provided better visual acuity and comfort compared to soft spherical contact lenses (SCL), with a significant improvement in monocular vision (P=0.01) and less fatigue (P=0.04).

A majority of participants (79%) preferred the TCL over SCL, indicating that offering TCL as the first option for patients with low-to-moderate astigmatism may lead to better patient satisfaction and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does offering only the spherical contact lens trial to the low astigmats mislead the practitioners? Chaudhry, M., Sah, SP., Sharma, IP., et al.[2021]

In a study involving 581 myopic children aged 7-15 years wearing daily disposable hydrogel contact lenses, no significant or serious ocular adverse events were reported over 816 patient years, indicating a high safety profile for these lenses.

The overall rate of ocular adverse events was low at 10.6 per 100 patient years, with only two non-significant corneal infiltrative events, suggesting that daily disposable soft contact lenses are a safe option for children compared to a lower incidence of 1.8 per 100 patient years for spectacle wearers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. Cheng, X., Brennan, NA., Toubouti, Y., et al.[2021]

The Contact Lens Risk Survey (CLRS) is a reliable and valid tool developed from data collected from 1,059 participants, designed to identify risk factors for complications related to soft contact lens use, particularly red eye events.

The survey demonstrated excellent internal consistency and repeatability, with a good ability to distinguish between individuals with and without red eye symptoms, making it a useful resource for improving patient safety in contact lens wearers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a contact Lens risk survey. Mitchell, GL., Richdale, K., Lam, D., et al.[2021]

Rigid contact lenses are associated with significantly fewer serious adverse events compared to soft contact lenses, with 4 events for rigid lenses versus 16 for soft lenses in a study of 100 subjects over 12 months.

Experienced contact lens wearers are less likely to discontinue use compared to new wearers, with 5 experienced users discontinuing versus 18 neophytes, highlighting the importance of experience in lens tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and discontinuations with rigid and soft hyper Dk contact lenses used for continuous wear. Morgan, PB., Efron, N., Maldonado-Codina, C., et al.[2019]

A study of 963 children aged 8-12 years wearing soft contact lenses (SCLs) showed that the rates of non-infectious inflammatory adverse events (AEs) were low, with an annualized rate of 0.66% for non-infectious AEs and 0.48% for contact lens papillary conjunctivitis.

The rate of microbial keratitis (MK) was found to be 7.4 cases per 10,000 years-of-wear, which is comparable to rates seen in adults, indicating that SCL wear in children is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event rates in the retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS study. Chalmers, RL., McNally, JJ., Chamberlain, P., et al.[2021]

The Contact Lens Assessment in Youth Contact Lens Risk Survey (CLRS) effectively differentiates between soft contact lens wearers with serious and significant adverse events and healthy controls, with serious cases scoring significantly higher (56.1) than controls (44.3).

The CLRS can help eye care practitioners identify patients at higher risk for contact lens-related issues, allowing for targeted interventions to reduce risky behaviors associated with contact lens wear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The contact Lens risk survey to assess risk of soft contact lens-related inflammatory events. Mickles, CV., Kinoshita, BT., Lam, D., et al.[2021]

Recent advancements in soft contact lenses for astigmatism, including toric, tinted, disposable, and bifocal options, have improved comfort and affordability.

As a result of these innovations, more patients with astigmatism are successfully using soft toric lenses compared to previous years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The correction of astigmatism with soft contact lenses. Russell, CH., Slonim, CB.[2019]

In a study of 100 eyes requiring significant astigmatic correction, soft toric contact lenses with back surface cylinder correction showed a significantly higher success rate compared to those with front surface cylinder correction.

Using back surface optics for astigmatism correction in soft toric lenses resulted in success rates that are comparable to those found in broader studies of soft lens fitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft toric lenses: correcting cylinder greater than sphere. Maltzman, BA., Rengel, A.[2017]

In a study of 24 eyes from 14 patients with keratoconus, the use of SoftPerm contact lenses significantly improved best-corrected visual acuity from 12.5% achieving 20/40 or better before fitting to 83.3% after fitting, demonstrating their efficacy for irregular astigmatism.

Despite the visual benefits, 29.1% of patients experienced lens damage and discomfort, which were the most common reasons for discontinuation, indicating that while SoftPerm lenses are effective, they may not be suitable for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective case series: use of SoftPerm contact lenses in patients with keratoconus. Ozkurt, Y., Oral, Y., Karaman, A., et al.[2022]

In a study of 40 myopic patients, visual performance was evaluated using spectacles and three types of soft contact lenses, revealing that wavefront analysis provided more sensitive measurements of visual function compared to traditional methods like high contrast visual acuity and contrast sensitivity.

While there were differences in refractive components between the contact lenses, overall visual performance in terms of acuity and contrast sensitivity was not significantly different among spectacles and the three contact lenses, indicating that all options may be similarly effective for myopic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Visual performance in myopic correction with spectacles and soft contact lenses]. Barth, B., Alves, MR., Kara-José, N.[2019]

Soft contact lenses can effectively improve vision in patients with irregular astigmatism after LASIK, as demonstrated in a case study of a 41-year-old man who achieved 20/20 vision with the right eye using a specific soft lens.

The study showed that while soft lenses can reduce the appearance of corneal irregularities, some irregularity may still affect vision; however, the patient reported good comfort and functional vision with the lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft contact lenses for irregular astigmatism after laser in situ keratomileusis. Chou, B., Wachier, BS.[2022]

A 2-year clinical trial with 119 participants showed that frequent replacement of soft contact lenses (every 1 or 3 months) significantly reduces complications like microcysts and corneal staining compared to a non-replacement group.

Participants in the frequent replacement groups experienced higher satisfaction with their lenses and required fewer unscheduled replacements, highlighting the benefits of regular lens changes for eye health and comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular and subjective responses to frequent replacement of daily wear soft contact lenses. Pritchard, N., Fonn, D., Weed, K.[2018]

Approximately one third of potential soft contact lens wearers require correction for astigmatism, with a prevalence of 47.4% of patients showing at least 0.75 D of astigmatism in one eye.

A stock range of toric soft lenses can accommodate about 90% of astigmatic patients, requiring nearly 3,000 different prescriptions to cover various sphere powers, cylinder powers, and axes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of astigmatism in relation to soft contact lens fitting. Young, G., Sulley, A., Hunt, C.[2022]

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