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

Not Applicable

• Conditions: Refractive Errors
• Interventions: Device: HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens

• Registration Number: NCT02812316
• Lead Sponsor: Taipei Medical University Hospital

Brief 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

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-24
• Status Verified: 2016-11
• Primary Completion: 2017-02
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scleral lenses	HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens	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.

Primary Outcome Measures

Name	Time	Method
The success rate of the vision with correction	Wearing the contact lens for 6 months	* 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.

Secondary Outcome Measures

Name	Time	Method
The effectiveness of each visit	wearing the contact lens for 6 months	* 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.
The rate of Treatment-Emergent Adverse Events to assess the safety of each visit	wearing the contact lens for 6 months	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.

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan