Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: etafilcon A; Device: stenfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01707238

EX-MKTG-39

Details and patient eligibility

About

The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Full description

The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

Enrollment: 100 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:-

• Be between 16 and 45 years of age (inclusive)
• Adapted soft contact lens (CL) wearers (i.e. > 1 month)
• Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
• Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
• Correctable to 6/9 (20/30) in both eyes
• Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
• Have read, understood and signed the informed consent
• Willing to comply with the wear schedule (at least 40 hours per week)
• Willing to comply with the study visit schedule

Exclusion Criteria:-

• Any active corneal infection, injury or inflammation
• Systemic or ocular allergies, which might interfere with CL wear
• Systemic disease, which might interfere with CL wear
• Ocular disease, which might interfere with CL wear
• Strabismus, amblyopia
• Subjects who have undergone corneal refractive surgery and any anterior segment surgery
• Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
• Pregnant or lactating
• Use of systemic/topical medication contraindicating CL wear
• Use of gas permeable contact lenses within the last month
• Employees of the investigational site or immediate family members of Investigators
• Participation in any concurrent clinical trial or in the last 30 days

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

stenfilcon A

Experimental group

Description:

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Treatment:

Device: etafilcon A

etafilcon A

Active Comparator group

Description:

Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Treatment:

Device: stenfilcon A