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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: Orion daily disposable contact lens
* Device: Gemini daily disposable contact lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orion then Gemini<br>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. | Device: Orion daily disposable contact lens<br>* Subjects will be randomized to wear Orion lens for 2 weeks.<br>Device: Gemini daily disposable contact lens<br>* Subjects will be randomized to wear Gemini lens for 2 weeks.<br>|
| Experimental: Gemini then Orion<br>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. | Device: Orion daily disposable contact lens<br>* Subjects will be randomized to wear Orion lens for 2 weeks.<br>Device: Gemini daily disposable contact lens<br>* Subjects will be randomized to wear Gemini lens for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Comfort Satisfaction | Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied) | Baseline - After 10 minutes of lens dispense | 
| Subjective Overall Comfort Satisfaction | Overall comfort satisfaction analyzed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied) | 2 Weeks | 
| Subjective Preference for Comfort | Subjective preference for comfort (Orion strongly, Orion slightly, No preference, Gemini slightly, Gemini strongly) | 2 weeks | 
| Lens Surface Wettability Performance | 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) | Baseline - After 10 minutes of lens dispense | 
| Lens Surface Wettability Performance | 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) | 2 weeks | 
| Horizontal Lens Centration | 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) | Baseline - After 10 minutes of lens dispense | 
| Horizontal Lens Centration | 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) | 2 weeks | 
| Vertical Lens Centration | 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) | Baseline - After 10 minutes of lens dispense | 
| Vertical Lens Centration | 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) | 2 weeks | 
| Post-blink Movement | Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink | Baseline - after 10 minutes of lens dispense | 
| Post-blink Movement | Post-blink movement assessed on the amount of lens movement to the nearest 0.1mm immediately after the blink | 2 weeks | 
| Lens Horizontal Mobility Rating | Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile) | Baseline - after 10 minutes of lens dispense | 
| Lens Horizontal Mobility Rating | Lens Horizontal Mobility Rating on a scale of 0-4 (0-immobile, 1- restricted, 2- secure, 3- unrestricted, 4- very mobile) | 2 weeks | 
| Corneal Staining Extent | 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). | Baseline - after 10 minutes of lens dispense | 
| Corneal Staining Extent | 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). | 2 weeks | 
| Overall Lens Fit Acceptance | 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) | Baseline - after 10 minutes of lens dispense | 
| Overall Lens Fit Acceptance | 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) | 2 weeks | 
| Lens Handling Satisfaction | Lens handling satisfaction assessed on a 7-point Likert Scales (Very satisfied, satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied) | 2 weeks | 
| Subjective Overall Lens Handling | SubjectiveOverall Lens handling assessed on a scale of 0-100 (0- cannot be managed, 100- Excellent handling) | 2 weeks |