Evaluation Study on Corneal Lens for Vision Correction
1 other identifier
interventional
40
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 30, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedFebruary 4, 2014
January 1, 2014
9 months
January 30, 2014
February 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Acuity
30 mins
Study Arms (2)
Astigmatic Correction Lens
ACTIVE COMPARATORNexis ACCL lenses vs commercial Toric Lenses
Toric Soft Contact Lenses
ACTIVE COMPARATORcommercial toric soft contact lenses
Interventions
Astigmatic refractive error correction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FORSIGHT Vision3lead
Study Sites (6)
Cliff Leong
Fremont, California, 94538, United States
Sara Chiu
Fremont, California, 94538, United States
John Michelsen
Livermore, California, 94550, United States
Nexis Vision
Menlo Park, California, 94025, United States
Nick Chan
San Mateo, California, 94401, United States
Josephine Vo-Laurel
Stockton, California, 95219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley Tuan, OD, PhD
Nexisvision
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2014
First Posted
February 4, 2014
Study Start
February 1, 2013
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
February 4, 2014
Record last verified: 2014-01