Study to Evaluate the Safety and Efficacy of HI-BRITE Large Diameter Rigid Gas Permeable Contact … (NCT02812316) | Clinical Trial Compass
UnknownNot Applicable
Study to Evaluate the Safety and Efficacy of HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens
Taiwan136 participantsStarted 2014-08
Plain-language summary
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.
Who can participate
Age range20 Years – 65 Years
SexALL
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Inclusion criteria:
* Ametropic or irregular cornea subjects who need to wear spectacle lens or contact lens in their daily life.
* Is of age at least 20 years old and no older than 65 years old capacity to volunteer.
* Has read and signed the Informed Consent Form or waiver. (4) Has myopia or hyperopia -20.00D~+20.00D, astigmatism -0.25\~-4.00D, or presbyopia +1.00D~+3.50D.
* Irregular cornea subjects include keratoconus, high astigmatism (\>-4.00D) or post-refractive surgery patients.
* No active ocular disease, infection or any disorder of eyelids and conjunctiva.
* Has reasonable expectation of improvement in visual acuity with the test lenses.
* Is willing and able to follow subject instructions and meet the protocol -specified visit schedule. (If subjects missed any visit, they must be discontinued from the study.) (9) Agrees to wear the test lenses at a daily wear basis. (10) Willing to adapt wearing GP contact lens.
Exclusion criteria:
The subject is ineligible for entry into the study if the subject
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will, in the Investigator's opinion. Affect ocular physiology or lens performance within one (1) week before entering this study.
* Has an active ocular disease or has ever used systemic steroid or any other medicine that may affect significant on vision or healing.
* Has any Grade 2 or greater finding listed in the Quantification of Slit Lamp Observations Form. Sub…