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Evaluation Study on Corneal Lens for Vision Correction

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Astigmatic Correction Lens (Nexis ACCL lenses)
Toric Soft Contact Lenses
Sponsored by
FORSIGHT Vision3
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism

Eligibility Criteria

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

Inclusion Criteria:

  1. Patient with good corneal health
  2. Age 18-65.
  3. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements.
  4. Best corrected visual acuity of 20/20 or better in the study eye/s

Exclusion Criteria:

  1. Any other anterior segment abnormality.
  2. No previous corneal procedures, including Laser Vision Correction.
  3. Any abnormalities associated with the eye lids.
  4. Clinically significant inflammation or infection within six (6) months prior to study.
  5. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
  6. Participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses.
  7. Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material.
  8. Specifically known intolerance or hypersensitivity to contact lenses.
  9. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Sites / Locations

  • Cliff Leong
  • Sara Chiu
  • John Michelsen
  • Nexis Vision
  • Nick Chan
  • Josephine Vo-Laurel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Astigmatic Correction Lens

Toric Soft Contact Lenses

Arm Description

Nexis ACCL lenses vs commercial Toric Lenses

commercial toric soft contact lenses

Outcomes

Primary Outcome Measures

Visual Acuity

Secondary Outcome Measures

Full Information

First Posted
January 30, 2014
Last Updated
February 2, 2014
Sponsor
FORSIGHT Vision3
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1. Study Identification

Unique Protocol Identification Number
NCT02053688
Brief Title
Evaluation Study on Corneal Lens for Vision Correction
Official Title
Evaluation Study on Corneal Lens for Vision Correction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FORSIGHT Vision3

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the fitting and visual outcomes of Nexis Lens, made of silicone commonly used in the contact lens industry, on healthy eye with or without astigmatism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astigmatic Correction Lens
Arm Type
Active Comparator
Arm Description
Nexis ACCL lenses vs commercial Toric Lenses
Arm Title
Toric Soft Contact Lenses
Arm Type
Active Comparator
Arm Description
commercial toric soft contact lenses
Intervention Type
Device
Intervention Name(s)
Astigmatic Correction Lens (Nexis ACCL lenses)
Intervention Description
Astigmatic refractive error correction
Intervention Type
Device
Intervention Name(s)
Toric Soft Contact Lenses
Intervention Description
astigmatism correction using toric optics
Primary Outcome Measure Information:
Title
Visual Acuity
Time Frame
30 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient with good corneal health Age 18-65. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements. Best corrected visual acuity of 20/20 or better in the study eye/s Exclusion Criteria: Any other anterior segment abnormality. No previous corneal procedures, including Laser Vision Correction. Any abnormalities associated with the eye lids. Clinically significant inflammation or infection within six (6) months prior to study. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator. Participation in any study involving an investigational drug or device within the past 30 calendar days, or ongoing participation in a study with an investigational material except studies using corneal lenses. Intolerance or hypersensitivity to topical anesthetics, fluorescein, or components of the material. Specifically known intolerance or hypersensitivity to contact lenses. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Tuan, OD, PhD
Organizational Affiliation
Nexisvision
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliff Leong
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Sara Chiu
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
John Michelsen
City
Livermore
State/Province
California
ZIP/Postal Code
94550
Country
United States
Facility Name
Nexis Vision
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
Nick Chan
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Josephine Vo-Laurel
City
Stockton
State/Province
California
ZIP/Postal Code
95219
Country
United States

12. IPD Sharing Statement

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Evaluation Study on Corneal Lens for Vision Correction

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