Clinical trial NCT05933772: Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
Official title: Performance Evaluation of Two Silicone Hydrogel 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
Collaborators: name: Centre for Ocular Research & Education, Canada
First posted: 2023-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lens Handling on Removal
timeFrame: At the end of one month of wear
Secondary outcomes:
measure: Distance Visual Acuity
timeFrame: At the end of one month of wear
Other outcomes:
Locations:
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: Toronto
country: Canada
facility: Eyes on Sheppard Clinic
state: Ontario
city: Toronto
country: Canada
facility: Spadina Optometry
state: Ontario
Study officials:
affiliation: Sacco Eye Group
name: Andrew Sacco
role: PRINCIPAL_INVESTIGATOR
affiliation: Spadina Optometry
name: David Wilkinson
role: PRINCIPAL_INVESTIGATOR
affiliation: Eyes on Sheppard Clinic
name: Fiona Soong
role: PRINCIPAL_INVESTIGATOR
affiliation: ProCare Vision Center
name: Katherine Bickle
role: PRINCIPAL_INVESTIGATOR
affiliation: Kannarr Eye Care
name: Shane R. Kannarr
role: PRINCIPAL_INVESTIGATOR
References: