A Clinical Trial to Evaluate Investigational Silicone Hydrogel Contact Lenses Worn Continuously for One Week

NCT ID: NCT02543528

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2016-11-08

Brief Summary

This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of ~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.

Conditions

Visual Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

etafilcon A (1-Day) and etafilcon A (Reusable)

Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

Group Type: EXPERIMENTAL

etafilcon A (Reusable)

Intervention Type: DEVICE

One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.

etafilcon A (1-Day)

Intervention Type: DEVICE

2-week contact lens adaptation period wearing prior to randomization

etafilcon A (1-Day) and Investigational Lens 1

Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

Group Type: EXPERIMENTAL

Investigational Lens 1

Intervention Type: DEVICE

One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

etafilcon A (1-Day)

Intervention Type: DEVICE

2-week contact lens adaptation period wearing prior to randomization

etafilcon A (1-Day) and Investigational Lens 2

Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

Group Type: EXPERIMENTAL

Investigational Lens 2

Intervention Type: DEVICE

One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

etafilcon A (1-Day)

Intervention Type: DEVICE

2-week contact lens adaptation period wearing prior to randomization

etafilcon A (1-Day) and Investigational Lens 3

Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

Group Type: EXPERIMENTAL

Investigational Lens 3

Intervention Type: DEVICE

One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

etafilcon A (1-Day)

Intervention Type: DEVICE

2-week contact lens adaptation period wearing prior to randomization

Interventions

Investigational Lens 1

One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

Intervention Type: DEVICE

Investigational Lens 2

One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

Intervention Type: DEVICE

Investigational Lens 3

One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.

Intervention Type: DEVICE

etafilcon A (Reusable)

One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.

Intervention Type: DEVICE

etafilcon A (1-Day)

2-week contact lens adaptation period wearing prior to randomization

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The subject must read and understand English and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must be at least 18 and no more than 39 years of age.
• The subject's spherical equivalent distance refraction must be in the range of -1.00 to -5.50 diopters in each eye.
• The subject's refractive cylinder must be less than 1.00 diopters in each eye.
• The subject must have best corrected visual acuity of 20/30 or better in each eye.
• The subject must be without history of contact lens use in the past 12 months.
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria

• Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month)
• Currently pregnant or lactating (self reported) (subjects who become pregnant during the study will be discontinued).
• Currently a regular smoker (1 or more times per month).
• Current routine swimmer (1 or more times per month).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease (ex. Sjögren's Syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), which may interfere with contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
• Any previous or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.).
• Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self report).
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Research Foundation, Sankara Nethralaya

Chennai, , India

Countries

India

Other Identifiers

CR-5201

Identifier Type: -

Identifier Source: org_study_id