Status:
UNKNOWN
Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses
Lead Sponsor:
HOYA Lamphun Ltd
Conditions:
Contact Lenses
Eligibility:
All Genders
20+ years
Phase:
NA
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 mea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03859440
Start Date
May 1 2019
End Date
October 1 2019
Last Update
March 7 2019
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