Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens

Johnson & Johnson (J&J)

Status: Completed

Conditions: Myopia

Treatments: Device: Galyfilcon A 8.7 BC (Investigational); Device: Galyfilcon A Habitual Lens; Device: Galyfilcon A 8.3 BC (Investigational)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01054807

CTN# 155/2009 (Registry Identifier)

CR-0915

Details and patient eligibility

About

The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be of legal age (i.e., at least 18 years old)
• Sign a written informed consent
• Have contact lens distance sphere requirement in the range -1.00D to -6.00D
• Have spectacle astigmatism <1.25D in each eye
• Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
• Have normal eyes with no evidence of abnormality or disease.

Exclusion criteria

• Required concurrent ocular medication
• Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
• Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
• Abnormal lacrimal secretions
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• Pregnancy, lactating or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial
• Known allergy to silver, silver ions, or silver containing compounds.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

32 participants in 6 patient groups

GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3

Other group

Description:

Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)

Treatment:

Device: Galyfilcon A 8.3 BC (Investigational)

Device: Galyfilcon A 8.7 BC (Investigational)

Device: Galyfilcon A Habitual Lens

Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL

Other group

Description:

Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)

Treatment:

Device: Galyfilcon A 8.3 BC (Investigational)

Device: Galyfilcon A 8.7 BC (Investigational)

Device: Galyfilcon A Habitual Lens

GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7

Other group

Description:

Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)

Treatment:

Device: Galyfilcon A 8.3 BC (Investigational)

Device: Galyfilcon A 8.7 BC (Investigational)

Device: Galyfilcon A Habitual Lens

Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3

Other group

Description:

Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)

Treatment:

Device: Galyfilcon A 8.3 BC (Investigational)

Device: Galyfilcon A 8.7 BC (Investigational)

Device: Galyfilcon A Habitual Lens

Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7

Other group

Description:

Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)

Treatment:

Device: Galyfilcon A 8.3 BC (Investigational)

Device: Galyfilcon A 8.7 BC (Investigational)

Device: Galyfilcon A Habitual Lens

Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL

Other group

Description:

Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)

Treatment:

Device: Galyfilcon A 8.3 BC (Investigational)

Device: Galyfilcon A 8.7 BC (Investigational)

Device: Galyfilcon A Habitual Lens