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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859440
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
HOYA Lamphun Ltd

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.


Condition or disease Intervention/treatment Phase
Contact Lenses Device: DSiHy Silicone hydrogel soft contact lens Device: CE-marked Silicone hydrogel soft contact lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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





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

Secondary Outcome Measures :
  1. The following variables will be compared between lens types: Corneal staining - type (mean grade, 0-4) [ Time Frame: 13 week visit ]

    Assessed by sector with fluorescein, blue light, yellow filter and full beam using medium magnification.

    0 NONE: No staining

    1. Micropunctate - Punctate staining, minor localized or scattered in on one or two quadrants
    2. Macropunctate - Coalescent punctate staining, localized in one or two quadrants
    3. Widespread coalescent punctate staining in more than two quadrants
    4. Confluent staining or erosion (usually accompanied by hyperemia)

  2. The following variables will be compared between lens types: Limbal hyperemia (grade, 0-4) [ Time Frame: 13 week visit ]

    Assessed using slit lamp with white light, low-medium magnification 0 NONE: No injection present

    1. TRACE: Slight limbal (mild segmented), bulbar (mild regional), and/or palpebral injection
    2. MILD: Mild limbal (mild circumcorneal), bulbar (mild diffuse) injection
    3. MODERATE: Significant limbal (marked segmented), bulbar (marked regional or diffuse) injection
    4. SEVERE: Severe limbal (marked circumcorneal), bulbar (diffuse episcleral or scleral) injection

  3. The following variables will be compared between lens types: Bulbar hyperemia (grade, 0-4). [ Time Frame: 13 week visit ]

    Assessed using slit lamp with white light, low-medium magnification 0 NONE: No injection present

    1. TRACE: Slight limbal (mild segmented), bulbar (mild regional), and/or palpebral injection
    2. MILD: Mild limbal (mild circumcorneal), bulbar (mild diffuse) injection
    3. MODERATE: Significant limbal (marked segmented), bulbar (marked regional or diffuse) injection
    4. SEVERE: Severe limbal (marked circumcorneal), bulbar (diffuse episcleral or scleral) injection

  4. The following variables will be compared between lens types: Comfort (0-10) [ Time Frame: 13 week visit ]
    Assessed by subject. 0 to 10 scale 10 = cannot be felt 0 = painful

  5. The following variables will be compared between lens types: Visual acuity (logMAR VA) [ Time Frame: 13 week visit ]
  6. The following variables will be compared between lens types: Wettability (0-4). [ Time Frame: 13 week visit ]

    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.

    1. POOR: Irregular surface appearance; drying time <interblink period.
    2. ACCEPTABLE: Smooth surface appearance immediately after the blink becoming irregular with time; drying time >interblink period.
    3. GOOD: Typical lens appearance with long drying time.
    4. EXCELLENT: Appearance of a healthy cornea with very long drying time.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859440


Contacts
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Contact: Atsushi Uchida +81 3 5913 2378 atsushi.uchida@hoya.com

Sponsors and Collaborators
HOYA Lamphun Ltd
Investigators
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Principal Investigator: Graeme Young, Dr Visioncare Research Ltd.

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Responsible Party: HOYA Lamphun Ltd
ClinicalTrials.gov Identifier: NCT03859440     History of Changes
Other Study ID Numbers: HOYA-3601
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No