Phase
Condition
Eye Disorders/infections
Myopia
Treatment
DSiHy Silicone Hydrogel Soft Contact Lens
Daily Silicone Hydrogel Contact Lenses (oB)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be 18 years of age inclusive
Beside myopia and astigmatism, subjects with normal eyes and are not using anyocular medications (excluding ocular lubricants and artificial tears)
Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes
With +8.00D ~ -12.00 D spherical component myopia, and ≤1.00 astigmatism (based onmanifest refraction measurements)
Have worn soft contact lens for at least 2 month prior to the study
Willing to comply with the required wearing time
Agree to comply with all study procedures, sign and date the informed consent formbefore starting the clinical study
Exclusion
Exclusion Criteria:
Anterior segment infection, inflammation or abnormality
Any active ocular disease that would affect contact lens wear or vision (such asacute and subacute inflammation of the anterior chamber of the eye, eye infection,uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epitheliumabrasion, dry eye and tear duct defection, ocular allergies, highly suspectedglaucoma) upon evaluation by the investigators or slit lamp findings
Currently using systemic or ocular medications that would contraindicate contactlens wear (such as glaucoma eye drops, steroid anti-inflammatory drops, eyeointments, eye gels and other eye medicines)
History of herpetic keratitis
History of refractive surgery, keratoconus or irregular cornea
Slit lamp findings that are not suitable for inclusion (Details of the gradingstandards for each eye condition are specified in CIP section 5.7.5)
A pathologically dry eye (Schirmer test 1 <5 mm)
Have participated in any contact lens or contact lens care product clinical trialswithin the previous 1 month (excluding questionnaire types and specimen collection)
Currently pregnant, lactating, or planning to be pregnant during the trial
Have experienced discomfort when wearing silicone hydrogel contact lens, or a knownallergy to hyaluronic acid and sodium alginate
Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
Subjects who are judged by the investigators as unsuitable for the study
Study Design
Connect with a study center
Chang Gung Memorial Hospital, Taipei
Taipei,
TaiwanSite Not Available
Tri-Service General Hospital
Taipei, 114202
TaiwanActive - Recruiting
Chang Gung Memorial Hospital, Taipei
Taipei 1668341,
TaiwanSite Not Available
Tri-Service General Hospital
Taipei 1668341, 114202
TaiwanSite Not Available
Chang Gung Memorial Hospital, Linkou
Taoyuan,
TaiwanSite Not Available
Chang Gung Memorial Hospital, Linkou
Taoyuan District 1667905,
TaiwanSite Not Available

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