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

NCT02543528 | Completed Results DMC FDA Device

• 1 other identifier: CR-5201
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)

  The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.

  Up to 6 months

Secondary Outcomes (2)

• Overall Comfort Score

  Time Frame Up to 6 months

• Overall Vision Score

  Time Frame Up to 6 months

Study Arms (4)

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

EXPERIMENTAL

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.

Device: etafilcon A (Reusable); Device: etafilcon A (1-Day)

etafilcon A (1-Day) and Investigational Lens 1

EXPERIMENTAL

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.

Device: Investigational Lens 1; Device: etafilcon A (1-Day)

etafilcon A (1-Day) and Investigational Lens 2

EXPERIMENTAL

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.

Device: Investigational Lens 2; Device: etafilcon A (1-Day)

etafilcon A (1-Day) and Investigational Lens 3

EXPERIMENTAL

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.

Device: Investigational Lens 3; Device: etafilcon A (1-Day)

Interventions

Investigational Lens 1 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) and Investigational Lens 1

Investigational Lens 2 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) and Investigational Lens 2

Investigational Lens 3 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) and Investigational Lens 3

etafilcon A (Reusable) 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) and etafilcon A (Reusable)

etafilcon A (1-Day) DEVICE

2-week contact lens adaptation period wearing prior to randomization

etafilcon A (1-Day) and Investigational Lens 1; etafilcon A (1-Day) and Investigational Lens 2; etafilcon A (1-Day) and Investigational Lens 3; etafilcon A (1-Day) and etafilcon A (Reusable)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Medical Research Foundation, Sankara Nethralaya

Chennai, 600 006, India

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elizabeth Dow -PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision

edow1@its.jnj.com

904-443-1061

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: September 7, 2015
• Study Start: June 1, 2015
• Primary Completion: November 8, 2016
• Study Completion: November 8, 2016
• Last Updated: October 1, 2019
• Results First Posted: March 29, 2018

Record last verified: 2019-09

Locations

IN (1)