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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2023-12-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lens A, Then Lens B

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

Group Type EXPERIMENTAL

Lens A (comfilcon A toric lens)

Intervention Type DEVICE

One month wear

Lens B (lehfilcon A toric lens)

Intervention Type DEVICE

One month wear

Lens B, Then Lens A

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

Group Type EXPERIMENTAL

Lens A (comfilcon A toric lens)

Intervention Type DEVICE

One month wear

Lens B (lehfilcon A toric lens)

Intervention Type DEVICE

One month wear

Interventions

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Lens A (comfilcon A toric lens)

One month wear

Intervention Type DEVICE

Lens B (lehfilcon A toric lens)

One month wear

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes