A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Orion daily disposable contact lens
Device: Gemini daily disposable contact lens

Registration Number: NCT04585646

Lead Sponsor: Coopervision, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Orion then Gemini	Gemini daily disposable contact lens	Subjects will be randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
Gemini then Orion	Orion daily disposable contact lens	Subjects will be randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
Orion then Gemini	Orion daily disposable contact lens	Subjects will be randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
Gemini then Orion	Gemini daily disposable contact lens	Subjects will be randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.

Primary Outcome Measures

Name	Time	Method
Subjective Response for Vision Satisfaction	Baseline - After 10 minutes of lens dispense	Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Response for Overall Vision Satisfaction	2 Weeks - at night	Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Response for Overall Vision Quality	2 weeks - Night Driving	Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)

Secondary Outcome Measures

Name	Time	Method
Subjective Overall Lens Handling	2 weeks	SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling)
Post-blink Movement	2 weeks	Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink
Lens Horizontal Mobility Rating	2 weeks	Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile)
Corneal Staining Extent	2 weeks	Corneal staining extent will be assessed on a scale of 0-4 (0- No Staining, 1- 1 to 15% of area, 2- 16 to 30% of area, 3- 31-45% of area, 4- \>45% of area).
Overall Lens Fit Acceptance	2 weeks	Overall Lens Fit Acceptance assessed on a scale of 0-4 (0-Can't be worn, 1- Poor but acceptable, 2- Fair, 3- Good, 4- Optimum)
Lens Handling Satisfaction	2 weeks	Lens handling satisfaction assessed on a 7-point Likert Scales (Very satisfied, satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Overall Comfort Satisfaction	2 Weeks	Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Preference for Comfort	2 weeks	Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly)
Lens Surface Wettability Performance	2 weeks	Lens Surface wettability performance was measured on a scale of 0-4, 0.25 steps (0-Very poor, 1 - Poor, 2- Acceptable, 3- Good, 4- Excellent)
Horizontal Lens Centration	2 weeks	Horizontal Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Nasal decentration given +ve value. temporal decentration given -ve value)
Vertical Lens Centration	2 weeks	Vertical Lens Centration assessed in primary gaze, white light, diffuse, low-medium magnification, with graticule on 0.1mm steps (Superior decentration given +ve value, inferior decentration given -ve value)