Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses

Brien Holden Vision Institute (BHVI)

Status: Completed

Conditions: Refractive Error; Presbyopia

Treatments: Device: Somofilcon A; Device: Etafilcon A; Device: Omafilcon A; Device: 58% Poly-HEMA; Device: Nelfilcon A; Device: Nesofilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02484586

CRTC2014-04

Details and patient eligibility

About

The aim of this study is to assess the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.

Full description

Prospective, double-masked, crossover, bilateral wear, dispensing clinical trial where participants will wear multiple prototype (test) and commercial (control) lenses.

Multiple prototype contact lens designs will be assessed against commercial control lenses during the study, where each design will be worn for up to a week. There will be a minimum 1 night washout period between lens designs.

Enrollment: 161 patients

Sex: All

Ages: 18 to 70 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 18 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.
• Is correctable to at least 6/12 (20/40) or better in each eye 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, Sjogrens 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. Ocular medication can be prescribed during the course of the trial as per standard optometric practice.
• 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. Note: 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.
• Eye surgery within 12 weeks immediately prior to enrolment for this trial.
• Previous corneal refractive surgery.
• Contraindications to contact lens wear.
• Known allergy or intolerance to ingredients in any of the clinical trial products.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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161 participants in 2 patient groups

Presbyope group

Other group

Description:

40 years and over with a reading add. Control lens: Etafilcon A, Nelfilcon A, Nesofilcon A, Somofilcon A, 58% Poly-HEMA Test lens: Etafilcon A Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by each participant for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.

Treatment:

Device: Nelfilcon A

Device: Etafilcon A

Device: Nesofilcon A

Device: 58% Poly-HEMA

Device: Etafilcon A

Device: Etafilcon A

Device: Somofilcon A

Device: Nelfilcon A

Non-Presbyope group

Other group

Description:

18-39 years with no reading add. Control lens: Etafilcon A, Nelfilcon A, Omafilcon A Test lens: Etafilcon A Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by participants for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.

Treatment:

Device: Nelfilcon A

Device: Etafilcon A

Device: Omafilcon A

Device: Etafilcon A

Device: Etafilcon A

Device: Nelfilcon A