Evaluation Study on Corneal Lens for Vision Correction

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Astigmatic Correction Lens (Nexis ACCL lenses); Device: Toric Soft Contact Lenses

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fremont, California, United States, 94538
      • Cliff Leong
    • Fremont, California, United States, 94538
      • Sara Chiu
    • Livermore, California, United States, 94550
      • John Michelsen
    • Menlo Park, California, United States, 94025
      • Nexis Vision
    • San Mateo, California, United States, 94401
      • Nick Chan
    • Stockton, California, United States, 95219
      • Josephine Vo-Laurel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Astigmatic Correction Lens; Nexis ACCL lenses vs commercial Toric Lenses	Device: Astigmatic Correction Lens (Nexis ACCL lenses); Astigmatic refractive error correction
Active Comparator: Toric Soft Contact Lenses; commercial toric soft contact lenses	Device: Toric Soft Contact Lenses; astigmatism correction using toric optics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Acuity	30 mins

Collaborators and Investigators

• Sponsor: FORSIGHT Vision3
• Investigators: Principal Investigator: Ashley Tuan, OD, PhD, Nexisvision

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: February 2, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 2, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CL001