Clinical Evaluation of Two Approved Contact Lenses

NCT02759692 | Completed Results FDA Device

• 1 other identifier: CR-5829
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 13

Brief Summary

Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Overall 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.

  7-Day Follow-up

• Overall Quality of Vision

  Overall quality of vision 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.

  7-Day Follow-up

Secondary Outcomes (4)

• Individual Patient Reported Outcomes (Items 1-5)

  7-Day Follow-up

• Individual Patient Reported Outcomes (Items 6-10)

  7-Day Follow-up

• Individual Patient Reported Outcomes (Items 11-14)

  7-Day Follow-up

• Individual Patient Reported Outcomes (Items 15-17)

  7-Day Follow-up

Study Arms (2)

Group 1 (Test/Control/Test)

ACTIVE COMPARATOR

Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL / TEST wearing sequence will wear lenses as daily disposable on both eyes for approximately one week each with no washout period between lenses for at least five days, and 8 hours per day.

Device: TEST Contact Lens; Device: CONTROL Contact Lens

Group 2 (Control/Test/Control)

ACTIVE COMPARATOR

Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST / CONTROL wearing sequence will wear lenses as daily disposable on both eyes for approximately one week each with no washout period between lenses for at least five days, and 8 hours per day.

Device: TEST Contact Lens; Device: CONTROL Contact Lens

Interventions

TEST Contact Lens DEVICE

Also known as: senofilcon A

Group 1 (Test/Control/Test); Group 2 (Control/Test/Control)

CONTROL Contact Lens DEVICE

Also known as: stenfilcon A

Group 1 (Test/Control/Test); Group 2 (Control/Test/Control)

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, 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 (and including) 18 and 39 years of age.
• The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day, worn for at least 30 days immediately preceding the study.
• Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye.
• Have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if:

• Currently pregnant or breastfeeding (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 autoimmune disease or use of medication, which may interfere with contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or 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, multi-focal, toric, or extended wear 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 that is likely to affect successful contact lens wear.
• Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (13)

Becky Bizzle, OD

Montgomery, Alabama, 36117, United States

Location

Complete Family Eye Care of Fruit Cove

Jacksonville, Florida, 32259, United States

Location

Golden Family Eyecare

Sarasota, Florida, 34232, United States

Location

St. Lucy's Vision Center

Tampa, Florida, 33625, United States

Location

Eye Associates of Winter Park

Winter Park, Florida, 32792, United States

Location

VisualEyes, Inc.

Roswell, Georgia, 30076, United States

Location

Advantage Eyecare Associates, LLC

Neodesha, Kansas, 66757, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Advanced Family Eye Care

Denver, North Carolina, 28037, United States

Location

Total Eye Care PA

Memphis, Tennessee, 38119, United States

Location

Brian Frazier, OD

Jacksonville, Texas, 17576, United States

Location

Timothy R. Poling, OD

Salem, Virginia, 24153, United States

Location

Ziegler Leffingwell Eyecare

West Allis, Wisconsin, 53227, United States

Location

Results Point of Contact

• Title: Brian Pall, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care Inc.

BPALL@its.jnj.com

904 443-1290

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 29, 2016
• First Posted: May 3, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 18, 2017
• Results First Posted: August 18, 2017

Record last verified: 2017-07

Locations

US (13)