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

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.

Study Overview

• Status: Unknown
• Conditions: Contact Lenses
• Intervention / Treatment: Device: DSiHy Silicone hydrogel soft contact lens; Device: CE-marked Silicone hydrogel soft contact lens

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Atsushi Uchida; Phone Number: +81 3 5913 2378; Email: atsushi.uchida@hoya.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: HOYA Lamphun Ltd
• Investigators: Principal Investigator: Graeme Young, Dr, Visioncare Research Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HOYA-3601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No