Clinical trial NCT04831515: Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Official title: Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

Detailed description: This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Self reports having a full eye examination in the previous two years;
* Anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum;
* Has refractive astigmatism at least -0.75DC in each eye, maximum -2.25DC;
* Has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees;
* Is myopic and requires a spectacle spherical component of -1.00D to -6.50D inclusively;
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen with the available lens parameters

Exclusion Criteria:

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

Primary outcomes:
measure: Overall Ease of Lens Handling
timeFrame: 1 week
Secondary outcomes:
measure: Visual Acuity
timeFrame: Baseline - after lenses have settled for 10 minutes
measure: Visual Acuity
timeFrame: 1 week
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Athens
country: United States
facility: Athens Eye Care
state: Ohio
Study officials:
affiliation: Centre for Ocular Research and Education
name: Lyndon Jones, PhD, FCOptom
role: STUDY_DIRECTOR
References: