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

NCT03859440 | Unknown

• 1 other identifier: HOYA-3601
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Contact Lenses

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• The following variables will be compared between lens types: Corneal staining - type (mean grade, 0-4)

  13 week visit

• The following variables will be compared between lens types: Limbal hyperemia (grade, 0-4)

  13 week visit

• The following variables will be compared between lens types: Bulbar hyperemia (grade, 0-4).

  13 week visit

• The following variables will be compared between lens types: Comfort (0-10)

  13 week visit

• The following variables will be compared between lens types: Visual acuity (logMAR VA)

  13 week visit

Study Arms (2)

DSiHy (test lens)

EXPERIMENTAL

Device: DSiHy Silicone hydrogel soft contact lens

Silicone hydrogel soft contact lens CE-marked for daily use

ACTIVE COMPARATOR

Device: CE-marked Silicone hydrogel soft contact lens

Interventions

DSiHy Silicone hydrogel soft contact lens DEVICE

•Device: DSiHy (test lens) Silicone hydrogel soft contact lens for daily disposable wear.

DSiHy (test lens)

CE-marked Silicone hydrogel soft contact lens DEVICE

・Device: Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Other Name : MyDay

Silicone hydrogel soft contact lens CE-marked for daily use

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HOYA Lamphun Ltd: lead

Study Officials

• Graeme Young, Dr

  Visioncare Research Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atsushi Uchida

CONTACT

+81 3 5913 2378; atsushi.uchida@hoya.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: March 1, 2019
• Study Start: May 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share