Evaluation Study on Corneal Lens for Vision Correction

Astigmatism Clinical Trial

Official title:

Evaluation Study on Corneal Lens for Vision Correction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053688
• Other study ID #: CL001
• Status: Completed
• Phase: N/A
• First received: January 30, 2014
• Last updated: February 2, 2014
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: FORSIGHT Vision3
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Astigmatic Correction Lens (Nexis ACCL lenses)
Astigmatic refractive error correction
• Toric Soft Contact Lenses
astigmatism correction using toric optics

Locations

Country	Name	City	State
United States	Cliff Leong	Fremont	California
United States	Sara Chiu	Fremont	California
United States	John Michelsen	Livermore	California
United States	Nexis Vision	Menlo Park	California
United States	Nick Chan	San Mateo	California
United States	Josephine Vo-Laurel	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
FORSIGHT Vision3

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity		30 mins	Yes