- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02812316
Study to Evaluate the Safety and Efficacy of HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens
April 25, 2017 updated by: Taipei Medical University Hospital
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 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 Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 110
- Taipei Medical University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Scleral lenses
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The success rate of the vision with correction
Time Frame: Wearing the contact lens for 6 months
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Wearing the contact lens for 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effectiveness of each visit
Time Frame: wearing the contact lens for 6 months
|
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wearing the contact lens for 6 months
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The rate of Treatment-Emergent Adverse Events to assess the safety of each visit
Time Frame: wearing the contact lens for 6 months
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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.
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wearing the contact lens for 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tsung-Jen Wang, Dr., Taipei Medical University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
February 1, 2017
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
February 26, 2016
First Submitted That Met QC Criteria
June 21, 2016
First Posted (Estimate)
June 24, 2016
Study Record Updates
Last Update Posted (Actual)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201210038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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