Comparing two types of soft contact lenses for people with low astigmatism

Short-term Study of Myday Sphere and Myday Toric Lenses in Existing Spherical Soft Contact Lenses Wearers With Low Astigmatism (Pacific)

This study is testing two types of soft contact lenses to see which one is more comfortable and gives better vision for people with low astigmatism who usually wear spherical lenses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 17 Years to 42 Years
• Sex: All
• Sponsor: CooperVision International Limited (CVIL) (Industry-sponsored)
• Locations: 1 site (Waterloo, Ontario)
• Trial ID: NCT06873048 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate and compare the performance of two different soft contact lenses in individuals who have low levels of refractive astigmatism and are habitual wearers of spherical soft contact lenses. Participants will wear either a control lens or a test lens over a two-week period, with assessments conducted on specific days to gather data on comfort and vision quality. The study will involve regular online questionnaires to monitor participants' experiences with the lenses. The goal is to determine which lens provides better visual performance and comfort for wearers.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 17 to 42 who are habitual wearers of spherical soft contact lenses and have low levels of astigmatism.

Not a fit: Patients who wear toric or multifocal contact lenses or those who are presbyopic may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved contact lens options for individuals with low astigmatism, enhancing their visual comfort and quality of life.

How similar studies have performed: Previous studies have shown promising results in comparing different types of contact lenses, indicating that this approach has potential for success.

Eligibility criteria

Inclusion Criteria:

1. At least 17 years and no more than 42 years of age.
2. Have read and signed the study consent form.
3. Are willing and able to follow instructions and maintain the appointment schedule.
4. Are habitual wearer of spherical soft contact lenses (not toric or multifocal design), any brand and any replacement frequency.
5. Are willing to wear the study contact lenses for 6 days a week while in this study and on three days (day 1, Day 7 and Day 13) for at least 12 hours.
6. Are willing to provide a contact email and telephone number and to use a device that allows them to respond to a short online questionnaire every 3 hours on days 1, 7 and 13 of each lens arm, while wearing one of the 2 study lenses.
7. Are non-presbyopic i.e. no requirement for a reading addition for routine daily tasks (self report).
8. Have astigmatism of either -0.50, -0.75, -1.00 or -1.25 DC in each eye by subjective sphero-cylindrical refraction.
9. Achieves at least 0.10 LogMAR in each eye by subjective sphero-cylindrical refraction.
10. Can be fit with available study contact lens powers of between +6.00 to -10.00 DS.
11. Demonstrate an acceptable fit with the study contact lenses.

Exclusion Criteria:

1. Are participating in any concurrent clinical interventional study.
2. Have worn rigid contact lenses in the last 3 months.
3. Have worn soft toric contact lenses in the past 3 months.
4. Have any known active ocular disease or allergies and/or infection.
5. Have clinically significant biomicroscopy findings or have an ocular condition that contraindicate contact lens wear.
6. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
7. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable or contraindicate wearing soft contact lenses.
8. Have known sensitivity to the diagnostic sodium fluorescein to be used in the study.
9. Have undergone refractive error surgery or intraocular surgery.
10. Are an employee of the Centre for Ocular Research \& Education directly involved in this study.

Where this trial is running

Waterloo, Ontario

• School of Optometry & Vision Science — Waterloo, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Lyndon Jones, PhD,FCOptom — Centre for Ocular Research and Education
• Study coordinator: Percy Lazon, PhD

Conditions Astigmatism; Myopia; Hyperopia