Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 4

Conditions: Contact Lens Base Curve (BC) Fit and Comfort

Treatments: Device: Contact Lenses with 8.5 BC; Device: Contact Lenses with 9.0 BC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537522

CR-5730

Details and patient eligibility

About

The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.

Enrollment: 72 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• The subject must be no less than 18 and no more than 45 years of age with no presbyopic add.
• The subject must be willing and able to adhere to the instructions set out in the protocol.
• The subject must be an adapted soft contact lens wearer in both eyes.
• The subject must be willing to wear the study contact lenses up to 14 hours/day.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
• The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
• The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
• The subject must require a visual correction in both eyes (no monofit or monovision allowed).
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion criteria

• Current 1-DAY ACUVUE® TruEye® wearers
• Anisometropia of 1.00 D or greater
• Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
• Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
• Any ocular infection
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
• Pregnancy or lactation
• Diabetes
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 4 patient groups

Test/Control - Phase 1

Experimental group

Description:

Over visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner.

Treatment:

Device: Contact Lenses with 9.0 BC

Device: Contact Lenses with 8.5 BC

Control/Test - Phase 1

Experimental group

Description:

Over visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner.

Treatment:

Device: Contact Lenses with 9.0 BC

Device: Contact Lenses with 8.5 BC

Test/Control - Phase 2

Experimental group

Description:

During Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner.

Treatment:

Device: Contact Lenses with 9.0 BC

Device: Contact Lenses with 8.5 BC

Control/Test - Phase 2

Experimental group

Description:

During Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner.

Treatment:

Device: Contact Lenses with 9.0 BC

Device: Contact Lenses with 8.5 BC