Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical performance of two daily disposable silicone hydrogel contact lenses. One of these lenses, the 'test' lens is an investigational product. This means that it has not yet been approved for commercial use and is not available for sale. The other lens (control) is a commercially available contact lens. The results of this study will be analysed to determine how the 'test' lens compares with the 'control' lens. The control lens has been chosen because it is a market leader and is well tried and tested. Participants who are in this study will need to have healthy eyes, except for the need to correct their eyesight. Up to 90 people who are aged 20 years or older will be considered for participation in this study. The study is designed to be approximately 3 months long.

Official Title
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Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses

Conditions
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Contact Lenses

Intervention / Treatment
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* Device: DSiHy Silicone hydrogel soft contact lens
* Device: CE-marked Silicone hydrogel soft contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be aged 20 years or more. Sign written informed consent. Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment). Contact lens sphere requirement between -1.00 to -6.00 D (inclusive). Refractive astigmatism (if present) less than or equal to 0.75 D in both eyes. Be correctable by sphero-cylindrical refraction to 6/7.5 (+0.10 logMAR 0.8 decimal) or better in each eye. Require visual correction in both eyes (monovision allowed, no monofit. Exclusion Criteria: Require toric or multifocal contact lenses. Concurrent ocular medication. Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance. Any systemic illness affecting contact lens wear or the medical treatment of which would affect vision or successful lens wear (including diabetes). Clinically significant (≥Grade 2) corneal staining, corneal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear. History of herpetic keratitis. Pathological dry eye. Aphakia or amblyopia. History of refractive surgery, keratoconus or other corneal irregularity. Pregnancy, lactating or planning a pregnancy at the time of enrolment. Participation in any concurrent clinical trial or within the last 30 days.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSiHy (test lens)<br> | Device: DSiHy Silicone hydrogel soft contact lens<br>* •Device: DSiHy (test lens) Silicone hydrogel soft contact lens for daily disposable wear.<br>|
| Active Comparator: Silicone hydrogel soft contact lens CE-marked for daily use<br> | Device: CE-marked Silicone hydrogel soft contact lens<br>* ・Device: Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Other Name : MyDay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens-related ocular adverse events requiring temporary or permanent discontinuation (resting eyes) as a proportion of follow-up eye examinations. |  | 13 week visit | 
| Proportion of eyes with visual acuity corrected to 6/6 or better (1.0 decimal) at each visit. |  | 13 week visit | 
| Proportion of eyes with best sphere-corrected visual acuity of 6/6 or better (1.0 decimal) at each visit. |  | 13 week visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The following variables will be compared between lens types: Corneal staining - type (mean grade, 0-4) | Assessed by sector with fluorescein, blue light, yellow filter and full beam using medium magnification. 0 NONE: No staining Micropunctate - Punctate staining, minor localized or scattered in on one or two quadrants Macropunctate - Coalescent punctate staining, localized in one or two quadrants Widespread coalescent punctate staining in more than two quadrants Confluent staining or erosion (usually accompanied by hyperemia) | 13 week visit | 
| The following variables will be compared between lens types: Limbal hyperemia (grade, 0-4) | Assessed using slit lamp with white light, low-medium magnification 0 NONE: No injection present TRACE: Slight limbal (mild segmented), bulbar (mild regional), and/or palpebral injection MILD: Mild limbal (mild circumcorneal), bulbar (mild diffuse) injection MODERATE: Significant limbal (marked segmented), bulbar (marked regional or diffuse) injection SEVERE: Severe limbal (marked circumcorneal), bulbar (diffuse episcleral or scleral) injection | 13 week visit | 
| The following variables will be compared between lens types: Bulbar hyperemia (grade, 0-4). | Assessed using slit lamp with white light, low-medium magnification 0 NONE: No injection present TRACE: Slight limbal (mild segmented), bulbar (mild regional), and/or palpebral injection MILD: Mild limbal (mild circumcorneal), bulbar (mild diffuse) injection MODERATE: Significant limbal (marked segmented), bulbar (marked regional or diffuse) injection SEVERE: Severe limbal (marked circumcorneal), bulbar (diffuse episcleral or scleral) injection | 13 week visit | 
| The following variables will be compared between lens types: Comfort (0-10) | Assessed by subject. 0 to 10 scale 10 = cannot be felt 0 = painful | 13 week visit | 
| The following variables will be compared between lens types: Visual acuity (logMAR VA) |  | 13 week visit | 
| The following variables will be compared between lens types: Wettability (0-4). | Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification. 0 VERY POOR: Immediately displaying non-wetting areas on lens surface. POOR: Irregular surface appearance; drying time <interblink period. ACCEPTABLE: Smooth surface appearance immediately after the blink becoming irregular with time; drying time >interblink period. GOOD: Typical lens appearance with long drying time. EXCELLENT: Appearance of a healthy cornea with very long drying time. | 13 week visit |