Clinical trial NCT04585646: A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
Official title: A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.

Detailed description: The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear. This is a double-masked, randomized, bilateral, two-week crossover, dispensing study.

Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Is no greater than 55 years of age.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
* Has spectacle cylinder ≤1.00D in both eyes.
* Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
* Wears CLs in both eyes (monovision acceptable, but not monofit)
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.
* Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Exclusion Criteria:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has strabismus/amblyopia.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
* Is participating in any concurrent clinical or research study.

Primary outcomes:
measure: Subjective Response for Vision Satisfaction
timeFrame: Baseline - After 10 minutes of lens dispense
measure: Subjective Response for Overall Vision Satisfaction
timeFrame: 2 Weeks
measure: Subjective Response for Overall Vision Satisfaction
timeFrame: 2 Weeks - at night
measure: Subjective Response for Overall Vision Quality
timeFrame: Baseline - After 10 minutes of lens dispense
measure: Subjective Response for Overall Vision Quality
timeFrame: 2 weeks
measure: Subjective Response for Overall Vision Quality
timeFrame: 2 weeks - Night Driving
Secondary outcomes:
measure: Subjective Overall Comfort Satisfaction
timeFrame: Baseline - After 10 minutes of lens dispense
measure: Subjective Overall Comfort Satisfaction
timeFrame: 2 Weeks
measure: Subjective Preference for Comfort
timeFrame: 2 weeks
measure: Lens Surface Wettability Performance
timeFrame: Baseline - After 10 minutes of lens dispense
measure: Lens Surface Wettability Performance
timeFrame: 2 weeks
measure: Horizontal Lens Centration
timeFrame: Baseline - After 10 minutes of lens dispense
measure: Horizontal Lens Centration
timeFrame: 2 weeks
measure: Vertical Lens Centration
timeFrame: Baseline - After 10 minutes of lens dispense
measure: Vertical Lens Centration
timeFrame: 2 weeks
measure: Post-blink Movement
timeFrame: Baseline - after 10 minutes of lens dispense
measure: Post-blink Movement
timeFrame: 2 weeks
measure: Lens Horizontal Mobility Rating
timeFrame: Baseline - after 10 minutes of lens dispense
measure: Lens Horizontal Mobility Rating
timeFrame: 2 weeks
measure: Corneal Staining Extent
timeFrame: Baseline - after 10 minutes of lens dispense
measure: Corneal Staining Extent
timeFrame: 2 weeks
measure: Overall Lens Fit Acceptance
timeFrame: Baseline - after 10 minutes of lens dispense
measure: Overall Lens Fit Acceptance
timeFrame: 2 weeks
measure: Lens Handling Satisfaction
timeFrame: 2 weeks
measure: Subjective Overall Lens Handling
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: CORL, Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Pete S Kollbaum
role: PRINCIPAL_INVESTIGATOR
References: