Pilot Clinical Evaluation of Approved Contact Lenses

NCT02540122 | Completed Phase 1 DMC FDA Device

• 1 other identifier: CR-5627
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.

Conditions

Vision Disorders

Outcome Measures

Primary Outcomes (1)

• Assessment of Bulbar Conjunctival Blood Flow Velocity

  Bulbar conjunctival microvascular responses among different types of contact lenses after a period of lens wear will be observed and evaluated for clinical relevance findings.

  4 contact lenses will be tested over a period of 21 days.

Study Arms (2)

Subject A (Neophytes)

ACTIVE COMPARATOR

Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used.

Device: Marketed Contact Lens 1; Device: Marketed Contact Lens 2; Device: Marketed Contact Lens 3; Device: Marketed Contact Lens 4

Subject B (Habitual Lens Wearers)

ACTIVE COMPARATOR

Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used.

Device: Marketed Contact Lens 1; Device: Marketed Contact Lens 2; Device: Marketed Contact Lens 3; Device: Marketed Contact Lens 4

Interventions

Marketed Contact Lens 1 DEVICE

Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

Also known as: etafilcon A

Subject A (Neophytes); Subject B (Habitual Lens Wearers)

Marketed Contact Lens 2 DEVICE

Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

Also known as: nelfilcon A

Subject A (Neophytes); Subject B (Habitual Lens Wearers)

Marketed Contact Lens 3 DEVICE

Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

Also known as: narafilcon A in 8.5 base curve

Subject A (Neophytes); Subject B (Habitual Lens Wearers)

Marketed Contact Lens 4 DEVICE

Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

Also known as: narafilcon A in 9.0 base curve

Subject A (Neophytes); Subject B (Habitual Lens Wearers)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must read, understand, 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 not more than 70 years of age.
• The subject's refractive cylinder must be \< 1.00 Diopters (D) in each eye.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.
• The subject must be either a neophyte or a habitual and adapted wearer of soft contact lenses in both eyes.
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

You may not qualify if:

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted 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.
• Monovision or multi-focal contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 14 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).
• Suspicion of or recent history of alcohol or substance abuse.
• History of serious mental illness.
• History of seizures.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

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

Study Officials

• Hong Jiang, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 3, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

US (1)