Study to evaluate the safety and efficacy of HI-BRITE large diameter rigid gas permeable contact lens (hexafocon b) test when worn on a daily wear basis in the correction of myopia/hyperopia/astigmatism/presbyopia/ and irregular cornea.
Subjects who meet all eligible requirements for entry into the study will be instructed to insert the Hi-Brite Large Diameter Rigid Gas Permeable contact lens in daily wear basis for clinical evaluation purposes. Treatment period: 6 months
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
136
Approximately At least one hundred and forty (140) subjects (280 eyes) will be enrolled in this study at approximately two (2) clinical sites in Taiwan. All subjects will be fitted for and dispensed study lenses by each Investigator.
Taipei Medical University Hospital
Taipei, Taiwan
The success rate of the vision with correction
* Ametropic group: Subjects wear their lens for at least 6 hours/day and 5 days/ week after visit 9, Distance Lens VA is not less than 20/25 and 90% subjects' VA decreased less than 2 lines with Snellen's chart at the last visit. * Irregular Cornea Group: Subjects wear their lens for at least 6 hours/day and 5 days/ week after visit 9, Distance Lens VA is not less than 20/40 and 80% subjects' VA decreased less than 2 lines with Snellen's chart at the last visit.
Time frame: Wearing the contact lens for 6 months
The effectiveness of each visit
* Ametropic group: To assess each subject for the lens satisfied / problem and assess each time of the vision with correction; the ratio of ametropic correcting vision of 20/25 subjects. * Irregular Cornea Group: To assess each subject for the lens satisfied / problem and assess each time of the vision with correction; the ratio of the irregular cornea corrected visual acuity of 20/40 subjects.
Time frame: wearing the contact lens for 6 months
The rate of Treatment-Emergent Adverse Events to assess the safety of each visit
To assess the rate of adverse reactions, the proportion of corneal ulcers, the proportion of continuous stroma edema, significant proportion of corneal staining of luciferase, the proportion of corneal infections, the proportion of persistent inflammation of the eyelids, and the proportion of other eye discomfort.
Time frame: wearing the contact lens for 6 months
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