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

Primary Purpose

Refractive Errors

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Refractive Errors focused on measuring Myopia, Scleral lens, Astigmatism, Presbyopia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. Subjects with corneal infiltrates, however, of ANY GRADE, are not eligible.
  • Has any "Present" finding listed in the Quantification of Slit Lamp Observations that, in the Investigators' judgment, interferes with contact lens wear.
  • Has any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.
  • Severe dry eye (Schirmer Test<5mm/5min)
  • Corneal keratitis
  • Is aphakic
  • Had undertaken the following surgery: Retina, Glaucoma, Cataract surgery.
  • Is amblyopic, BSCVA can't achieve (include) 20/40(0.5) when wear trial lenses.
  • Allergy to contact lens solution.
  • ls participating in any other clinical research study.
  • Pregnancy or Breast-feeding.

Sites / Locations

  • Taipei Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scleral lenses

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 26, 2016
Last Updated
April 25, 2017
Sponsor
Taipei Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02812316
Brief Title
Study to Evaluate the Safety and Efficacy of HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Myopia, Scleral lens, Astigmatism, Presbyopia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scleral lenses
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens
Intervention Description
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.
Primary Outcome Measure Information:
Title
The success rate of the vision with correction
Description
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
Secondary Outcome Measure Information:
Title
The effectiveness of each visit
Description
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
Title
The rate of Treatment-Emergent Adverse Events to assess the safety of each visit
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Subjects with corneal infiltrates, however, of ANY GRADE, are not eligible. Has any "Present" finding listed in the Quantification of Slit Lamp Observations that, in the Investigators' judgment, interferes with contact lens wear. Has any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study. Severe dry eye (Schirmer Test<5mm/5min) Corneal keratitis Is aphakic Had undertaken the following surgery: Retina, Glaucoma, Cataract surgery. Is amblyopic, BSCVA can't achieve (include) 20/40(0.5) when wear trial lenses. Allergy to contact lens solution. ls participating in any other clinical research study. Pregnancy or Breast-feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsung-Jen Wang, Dr.
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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