NCT02812316

Study to Evaluate the Safety and Efficacy of HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens	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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-02-01
• Completion: 2017-10-01
• First posted: 2016-06-24
• Last updated: 2017-04-27

Locations

1 site across 1 country: Taiwan