Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: stenfilcon A; Device: narafilcon A; Device: delefilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02637804

JP-MKTG-201512

Details and patient eligibility

About

Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A

This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.

Full description

The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A.

The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.

Study groups:

Group 1: stenfilcon A vs. narafilcon A

Group 2: stenfilcon A vs. delefilcon A

Enrollment: 106 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Is over 18 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
• Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
• Can achieve a distance visual acuity of 20/30 or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter.
• Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
• Is willing to comply with the wear schedule.
• Is willing to comply with the visit schedule

Exclusion criteria

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

• Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
• Has a CL prescription outside the range of the inclusion power range
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
• Has contact lens best corrected distance vision worse than 20/25 in either eye
• Presence of clinically significant (grade 2-4) anterior segment abnormalities
• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
• Slit lamp findings that would contraindicate contact lens wear
• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• Has aphakia, keratoconus or a highly irregular cornea.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

stenfilcon A vs narafilcon A (Group 1)

Active Comparator group

Description:

Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.

Treatment:

Device: stenfilcon A

Device: narafilcon A

stenfilcon A vs delefilcon A (Group 2)

Active Comparator group

Description:

Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.

Treatment:

Device: stenfilcon A

Device: delefilcon A