Clinical Performance Evaluation of Two Silicone Hydrogel Lenses

NCT02756078 | Completed Results FDA Device

• 1 other identifier: CR-5816
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Overall CLUE Comfort

  Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

  Up to 4-Week Follow-up

Secondary Outcomes (6)

• Overall CLUE Handling

  Up to 4-Week Follow-up

• Time to Haze

  Up to 4-Week Follow-up

• Average Wear Time

  Up to 4-Week Follow-up

• Average Comfortable Wear Time

  Up to 4-Week Follow-up

• Difference in Total Device Use Time and Comfortable Wear Time During Device Use

  Up to 4-Week Follow-up

Study Arms (2)

Group 1 (TEST / CONTROL wear sequence)

ACTIVE COMPARATOR

Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.

Device: TEST Contact Lens; Device: CONTROL Contact Lens

Group 2 (CONTROL / TEST wear sequence)

ACTIVE COMPARATOR

Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.

Device: TEST Contact Lens; Device: CONTROL Contact Lens

Interventions

TEST Contact Lens DEVICE

Also known as: senofilcon A

Group 1 (TEST / CONTROL wear sequence); Group 2 (CONTROL / TEST wear sequence)

CONTROL Contact Lens DEVICE

Also known as: samfilcon A

Group 1 (TEST / CONTROL wear sequence); Group 2 (CONTROL / TEST wear sequence)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 between 18 and 40 years of age.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -8.00 D in each eye.
• The subject's refractive cylinder must be no more than -1.00 D cylindrical correction in each eye after vertexing to the corneal plane.
• The subject must have best corrected visual acuity of 0.20 or better in each eye.
• The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment.
• The subject must be using digital devices (any combination of computers, tablets, smart phones etc.) for at least 8 hours over the course of a typical day.
• The subject should own a wearable pair of spectacles and wear them the day of the baseline visit.
• The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
• The subject must meet normal eligibility conditions of binocular vision tests.
• The subject may not have any double vision at near with their habitual contact lens correction.

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 (at the investigator's discretion).
• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
• Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as a subject reporting headaches associated with birth control pills (at the investigator's discretion).
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
• Any active ocular infection.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
• 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 known hypersensitivity or allergic reaction to the study products.
• 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.
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

Results Point of Contact

• Title: Chantal Coles-Brennan - PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision Care, Inc.

CColesb@its.jnj.com

1-904-443-3449

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 29, 2016
• Study Start: April 8, 2016
• Primary Completion: October 2, 2017
• Study Completion: October 2, 2017
• Last Updated: November 14, 2018
• Results First Posted: October 25, 2018

Record last verified: 2018-10

Locations

CA (1)