Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

CooperVision International Limited (CVIL)

Status: Completed

Conditions: Astigmatism

Treatments: Device: Lens B (lehfilcon A toric lens); Device: Lens A (comfilcon A toric lens)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05933772

EX-MKTG-149

Details and patient eligibility

About

The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Full description

This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

Enrollment: 50 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Self-reports having a full eye examination in the previous two years;

4. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;

5. Is willing and able to follow instructions and maintain the appointment schedule;

6. Habitually wears of toric soft contact lenses binocularly.

   1. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;

   2. the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:

      • i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
      • ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
      • iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
      • iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
      • v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
      • vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
      • vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)

7. Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;

8. Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;

9. Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters

Exclusion criteria

1. Is participating in any concurrent clinical or research study;
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Has undergone refractive error surgery or intraocular surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Lens A, Then Lens B

Experimental group

Description:

Participants will wear Lens A for one month and then crossover to Lens B for one month.

Treatment:

Device: Lens A (comfilcon A toric lens)

Device: Lens B (lehfilcon A toric lens)

Lens B, Then Lens A

Experimental group

Description:

Participants will wear Lens B for one month and then crossover to Lens A for one month.

Treatment:

Device: Lens A (comfilcon A toric lens)

Device: Lens B (lehfilcon A toric lens)