A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens

Study Overview
=================
Brief Summary
-----------------
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.

Detailed Description
-----------------
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.

Official Title
-----------------
A Dispensing Clinical Trial of Invigor I Lens Against Clariti Lens

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Test lens
* Device: Control lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has had a self-reported oculo-visual examination in the last two years. Is at least 18 years of age and has full legal capacity to volunteer. Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. Currently wears soft contact lenses. Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps). Has no more than 0.75 diopters of refractive astigmatism. Has clear corneas and no active ocular disease. Has not worn lenses for at least 12 hours before the examination. Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit 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 undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study. Known allergy to a product used in this study (ex. Shellfish allergy) Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each subject will be randomized to wear the test or control contact lens for 1 month and then crossed-over to wear the other contact lens for 1 month.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test lens<br>Subjects wearing the test contact lens either as first or second pair during the cross-over study. | Device: Test lens<br>* Contact lens<br>* Other names: Invigor I lens;Device: Control lens<br>* Contact lens<br>* Other names: Clariti lens;|
| Active Comparator: Control lens<br>Subjects wearing the control contact lens either as first or second pair during the cross-over study. | Device: Test lens<br>* Contact lens<br>* Other names: Invigor I lens;Device: Control lens<br>* Contact lens<br>* Other names: Clariti lens;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | Baseline | 
| Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | 2-weeks | 
| Lens Surface Wettability | Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time << blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time) | 4-weeks | 
| Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits, 1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface) | Baseline | 
| Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface). | 2-weeks | 
| Lens Surface Deposits | Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (<0.1mm), 2: >5 deposits of <0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface) | 4-weeks | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | Baseline | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | 2-Weeks | 
| Overall Lens Fit Acceptance | Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum) | 4-Weeks | 
| Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | Baseline | 
| Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | 2-weeks | 
| Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration | Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (<0.5mm), Extremely decentered (>0.5mm) | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Baseline | 
| Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | 2-weeks | 
| Bulbar Conjunctiva Hyperaemia | Bulbar Conjunctiva Hyperaemia was measured on a scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | 4-weeks | 
| Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | Baseline | 
| Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | 2-weeks | 
| Limbal Conjunctiva Hyperaemia | Limbal Conjunctiva Hyperaemia was measured on a Scale of 0-4, 0.25 steps (0=None, 4=Severe injection) | 4-weeks |