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

Trial Summary

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 data supports the effectiveness of the treatment One week replacement soft contact lenses for astigmatism?

Research shows that soft contact lenses, including toric lenses designed for astigmatism, have improved significantly over the years, offering better comfort and effectiveness. These advancements have led to more astigmatic patients successfully using soft contact lenses. ^{1 2 3 4 5}

Are weekly replacement soft contact lenses for astigmatism safe for humans?

Research on soft contact lenses, including those for children and continuous wear, shows that while they are generally safe, there can be some risks of eye irritation or inflammation. It's important to follow proper hygiene and care instructions to minimize these risks. ^{6 7 8 9 10}

How do weekly replacement soft contact lenses for astigmatism differ from other treatments?

Weekly replacement soft contact lenses for astigmatism are unique because they are designed to be replaced every week, which can help reduce complications from lens contamination compared to lenses that are replaced less frequently. This frequent replacement schedule may offer better comfort and eye health for people with astigmatism. ^{1 2 11 12 13}

What is the purpose of this trial?

This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.

Eligibility Criteria

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

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

I have been diagnosed with dry eye disease.

I need reading glasses for close-up tasks.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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 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]

References

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

Soft contact lenses for irregular astigmatism after laser in situ keratomileusis. [2022]

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

Prevalence of astigmatism in relation to soft contact lens fitting. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

[Visual performance in myopic correction with spectacles and soft contact lenses]. [2019]

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

The correction of astigmatism with soft contact lenses. [2019]

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

Soft toric lenses: correcting cylinder greater than sphere. [2017]

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

Adverse events and discontinuations with rigid and soft hyper Dk contact lenses used for continuous wear. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Adverse event rates in the retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Safety of soft contact lenses in children: retrospective review of six randomized controlled trials of myopia control. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The contact Lens risk survey to assess risk of soft contact lens-related inflammatory events. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Development of a contact Lens risk survey. [2021]

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

Ocular and subjective responses to frequent replacement of daily wear soft contact lenses. [2018]

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

A retrospective case series: use of SoftPerm contact lenses in patients with keratoconus. [2022]

13. China pubmed.ncbi.nlm.nih.gov

Does offering only the spherical contact lens trial to the low astigmats mislead the practitioners? [2021]