Clinical Study of Approved and Investigational Contact Lenses

NCT02708524 | Completed Results DMC

• 1 other identifier: CR-5808
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 18

Brief Summary

This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (7)

• Subjective Overall Comfort Composite Score

  Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.

  Up to 1 month Follow-up

• Overall Comfort Individual Item

  Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

  1 month follow-up

• Comfort at the End of the Day Individual Item

  Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

  1 month Follow-up

• Comfort Each and Everyday Individual Item

  Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

  1 month Follow-up

• Frequency of Lens Awareness Individual Item

  Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.

  1 month Follow-up

• Frequency of Experiencing Dryness Individual Item

  Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.

  1 month Follow-up

• Making Your Eyes Feel Moist Throughout the Day Individual Item

  Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.

  Up to 1 month Follow-up

Secondary Outcomes (3)

• Subjective Overall Quality of Vision Composite Score

  Up to 1 month Follow-up

• Overall Quality of Vision Individual Item

  Up to 1 month Follow-up

• Overall Opinion Individual Item

  Up to 1 month Follow-up

Study Arms (4)

Senofilcon C Wearers

EXPERIMENTAL

Senofilcon C Wearers will wear the Senofilcon C Contact Lenses as daily wear for 30 (-2/+6) days.

Device: Senofilcon C Contact Lens

Comfilcon A Wearers

ACTIVE COMPARATOR

Comfilcon A Wearers will wear the Comfilcon A Contact Lens as daily wear for 30 (-2/+6) days.

Device: Comfilcon A Contact Lens

Lotrafilcon B Wearers

ACTIVE COMPARATOR

Lotrafilcon B Wearers will wear the Lotrafilcon B Contact Lens as daily wear for 30 (-2/+6) days.

Device: Lotrafilcon B Contact Lens

Samfilcon A Wearers

ACTIVE COMPARATOR

Samfilcon A Wearers will wear the Samfilcon A Contact Lens as daily wear for 30 (-2/+6) days.

Device: Samfilcon A Contact Lens

Interventions

Senofilcon C Contact Lens DEVICE

Also known as: senofilcon C

Senofilcon C Wearers

Comfilcon A Contact Lens DEVICE

Also known as: comfilcon A

Comfilcon A Wearers

Lotrafilcon B Contact Lens DEVICE

Also known as: lotrafilcon B

Lotrafilcon B Wearers

Samfilcon A Contact Lens DEVICE

Also known as: samfilcon A

Samfilcon A Wearers

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 to 40 years of age at the time of consent.
• The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
• The subject's refractive cylinder must be ≤1.00D in each eye.
• The subject must have best corrected visual acuity of 20/30 or better in each eye.
• The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
• The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

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, which may interfere with contact lens wear.
• Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
• Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
• 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.)
• 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 (18)

Unknown Facility

Montgomery, Alabama, United States

Location

Unknown Facility

Fruit Cove, Florida, United States

Location

Unknown Facility

Jacksonville, Florida, 32256, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Longwood, Florida, United States

Location

Unknown Facility

Tallahassee, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Roswell, Georgia, United States

Location

Unknown Facility

Bloomington, Illinois, United States

Location

Unknown Facility

East Lansing, Michigan, United States

Location

Unknown Facility

Medina, Minnesota, United States

Location

Unknown Facility

Closter, New Jersey, United States

Location

Unknown Facility

Vestal, New York, United States

Location

Unknown Facility

Granville, Ohio, United States

Location

Unknown Facility

Jacksonville, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Roanoke, Virginia, United States

Location

Unknown Facility

West Allis, Wisconsin, United States

Location

Results Point of Contact

• Title: Kristy Canavan, O.D. PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision Care Inc.

KCANAVA2@its.jnj.com

904-443-1474

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: March 3, 2016
• First Posted: March 15, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 9, 2016
• Results First Posted: November 9, 2016

Record last verified: 2016-09

Locations

US (18)