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Trial record 14 of 428 for:    Taipei Medical University Hospital

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

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ClinicalTrials.gov Identifier: NCT02812316
Recruitment Status : Unknown
Verified November 2016 by Taipei Medical University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Refractive Errors Device: HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens Not Applicable

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  (Clinical Trial)
Actual Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : August 2014
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. The success rate of the vision with correction [ Time Frame: 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 :
  1. The effectiveness of each visit [ Time Frame: 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.

  2. The rate of Treatment-Emergent Adverse Events to assess the safety of each visit [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812316


Locations
Taiwan
Taipei Medical University Hospital
Taipei, Taiwan, 110
Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Principal Investigator: Tsung-Jen Wang, Dr. Taipei Medical University Hospital

Responsible Party: Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT02812316     History of Changes
Other Study ID Numbers: 201210038
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Taipei Medical University Hospital:
Myopia
Scleral lens
Astigmatism
Presbyopia

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases