Evaluation Study on Corneal Lens for Vision Correction

ForSight VISION3

Status: Completed

Conditions: Astigmatism

Treatments: Device: Toric Soft Contact Lenses; Device: Astigmatic Correction Lens (Nexis ACCL lenses)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02053688

CL001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Astigmatic Correction Lens

Active Comparator group

Description:

Nexis ACCL lenses vs commercial Toric Lenses

Treatment:

Device: Astigmatic Correction Lens (Nexis ACCL lenses)

Toric Soft Contact Lenses

Active Comparator group

Description:

commercial toric soft contact lenses

Treatment:

Device: Toric Soft Contact Lenses