Performance and Safety of Silicone Hydrogel Soft Contact Lenses

ApexLens

Status: Unknown

Conditions: Myopia

Treatments: Device: ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens; Other: Contact Lens Case; Device: 41% Silicone Hydrogel Soft Contact Lenses(SHSCL); Other: Contact Lens Care Product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04226560

ApexLens-201901

Details and patient eligibility

About

To demonstrate substantial equivalence of the new Silicone Hydrogel Soft Contact Lenses(SHSCL) to the commercially available ACUVUE® VITA™ contact lens

Full description

This study is a prospective, subject-masked, bilateral, randomized, parallel group dispensing study comparing the SHSCL test lens against the 1-Month ACUVUE® VITA™ (1-MAV) control lenses. Each subject will be randomized to wear either the test or of the control with similar/comparable lens parameters optimized for vision.

Both test and control lens will be used in their daily wear, monthly replacement modality for thirteen (13) weeks. It is anticipated that this study will involve up to 6 scheduled visits.

Enrollment: 65 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

1. Healthy adult males or females age ≥20-45 years of age;
2. Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment) and the last contact lenses worn more than a week ago;
3. Have a contact lens powers between -2.00D and -6.00D (both inclusive) in both eyes;
4. Astigmatism of 1.00D or less in both eyes;
5. Be able to wear the lens powers available for this study;
6. Be correctable to a visual acuity of 0.8 decimal (+0.10 logMAR) or better in each eye;
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
8. The subject must read and sign the Informed Consent form.

Exclusion criteria

A person will be excluded from the study if he/she:

1. Previously unsuccessful with contact lens wear, worn rigid gas permeable contact lenses within past 12 months;
2. Women who are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
3. Any ocular or systemic allergies or diseases that may contraindicate contact lens wear;
4. Any ocular medications use within the last one month;
5. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear;
6. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report;
7. Any current or previous orthokeratology treatment, or planned for orthokeratology treatment during the study;
8. Any previous history of ocular and/or refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.), or planned for ocular and/or refractive surgery during the study
9. History of herpetic keratitis;
10. History of binocular vision abnormality or strabismus, by self-report;
11. Allergic reactions to test lens, control lens or the contact lens solution used in this study;
12. A clinical finding or history of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion, by self-report;
13. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician);
14. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment;
15. Any slit lamp findings which would contraindicate contact lens wear;
16. Any history of a contact lens-related corneal inflammatory event within the past 12 months that may contraindicate contact lens wear; or
17. Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures;
18. Subjects are considered ineligible for the study as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

41% Silicone hydrogel Soft contact lenses (SHSCL)

Experimental group

Description:

Healthy adult males or females age ≥20-45 years of age

Treatment:

Other: Contact Lens Care Product

Other: Contact Lens Case

Device: 41% Silicone Hydrogel Soft Contact Lenses(SHSCL)

ACUVUE® VITA™

Active Comparator group

Description:

Healthy adult males or females age ≥20-45 years of age

Treatment:

Other: Contact Lens Care Product

Other: Contact Lens Case

Device: ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens