Clinical trial NCT03859440: Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses
Official title: Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contact Lenses
Lead sponsor: HOYA Lamphun Ltd
Sponsor class: INDUSTRY
First posted: 2019-03-01
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Lens-related ocular adverse events requiring temporary or permanent discontinuation (resting eyes) as a proportion of follow-up eye examinations.
timeFrame: 13 week visit
measure: Proportion of eyes with visual acuity corrected to 6/6 or better (1.0 decimal) at each visit.
timeFrame: 13 week visit
measure: Proportion of eyes with best sphere-corrected visual acuity of 6/6 or better (1.0 decimal) at each visit.
timeFrame: 13 week visit
Secondary outcomes:
measure: The following variables will be compared between lens types: Corneal staining - type (mean grade, 0-4)
timeFrame: 13 week visit
measure: The following variables will be compared between lens types: Limbal hyperemia (grade, 0-4)
timeFrame: 13 week visit
measure: The following variables will be compared between lens types: Bulbar hyperemia (grade, 0-4).
timeFrame: 13 week visit
measure: The following variables will be compared between lens types: Comfort (0-10)
timeFrame: 13 week visit
measure: The following variables will be compared between lens types: Visual acuity (logMAR VA)
timeFrame: 13 week visit
measure: The following variables will be compared between lens types: Wettability (0-4).
timeFrame: 13 week visit
Other outcomes:
Locations:
Study officials:
affiliation: Visioncare Research Ltd.
name: Graeme Young, Dr
role: PRINCIPAL_INVESTIGATOR
References: