Visual Performance of Prototype Contact Lens Designs

Brien Holden Vision Institute (BHVI)

Status: Completed

Conditions: Refractive Error; Presbyopia

Treatments: Device: Etafilcon A, Senofilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02193555

CRTC2014-02

Details and patient eligibility

About

The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens

Full description

Prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. A minimum of an overnight washout period is required between the fitting /assessment visits.

Enrollment: 91 patients

Sex: All

Ages: 7+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Be at least 7 years old, male or female.
• Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
• Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses.
• Correctable to at least 6/12 (20/40) or better with both eyes with contact lenses.
• Be suitable and willing to wear contact lenses.

Exclusion criteria

• Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses.
• Any systemic disease that adversely affects ocular health e.g. diabetes, Graves' disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
• Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
• Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial.
• Eye surgery within 12 weeks immediately prior to enrolment for this trial.

NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.

Trial design

91 participants in 2 patient groups

Non-presbyopic group

Other group

Description:

Non-presbyopic group: age ranging from 7 to 39 years At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue 1- Day Moist, etafilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit. For each fitting visit, lenses will be fitted bilaterally.

Treatment:

Device: Etafilcon A, Senofilcon A

Presbyopic group

Other group

Description:

Presbyopic group: age 40 and above At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue Oasys for Presbyopia, senofilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit. For each fitting visit, lenses will be fitted bilaterally.

Treatment:

Device: Etafilcon A, Senofilcon A