Evaluation Study on Corneal Lens for Vision Correction

• Sponsor: FORSIGHT Vision3 (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02053688
• Collaborator: (none)
• Enrollment: 40
• Locations: 6
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: Astigmatic Correction Lens (Nexis ACCL lenses); Device: Toric Soft Contact Lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Evaluation Study on Corneal Lens for Vision Correction
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [30 mins]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliff Leong	Fremont	California	United States	94538
2	Sara Chiu	Fremont	California	United States	94538
3	John Michelsen	Livermore	California	United States	94550
4	Nexis Vision	Menlo Park	California	United States	94025
5	Nick Chan	San Mateo	California	United States	94401
6	Josephine Vo-Laurel	Stockton	California	United States	95219

Sponsors and Collaborators

• FORSIGHT Vision3

Investigators

• Principal Investigator: Ashley Tuan, OD, PhD, Nexisvision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: FORSIGHT Vision3
• ClinicalTrials.gov Identifier: NCT02053688
• Other Study ID Numbers: CL001
• First Posted: Feb 4, 2014
• Last Update Posted: Feb 4, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Astigmatism

Study Results

No Results Posted as of Feb 4, 2014