A Comparison of Two Daily Disposable Soft Contact Lenses

NCT02427477 | Completed Results

• 1 other identifier: CR-5698
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

Brief Summary

Approximately 120 subjects will be comparing two soft contact lenses for one week each.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Subjective Overall Comfort

  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.

  1-week Follow-up

• Subjective Overall Vision

  Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison 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.

  1-week Follow-up

Study Arms (2)

senofilcon A/ delefilcon A/ senofilcon A

EXPERIMENTAL

Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.

Device: senofilcon A; Device: delefilcon A

delefilcon A/senofilcon A/ delfilcon A

ACTIVE COMPARATOR

Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the delefilcon A contact lens then wore the senofilcon A contact lens second and then wore the Control lens delefilcon A contact lens third.

Device: senofilcon A; Device: delefilcon A

Interventions

senofilcon A DEVICE

Subjects will wear the contact lenses in both eyes for seven days

Also known as: senofilcon A Prototype

delefilcon A/senofilcon A/ delfilcon A; senofilcon A/ delefilcon A/ senofilcon A

delefilcon A DEVICE

Subjects will wear the contact lenses in both eyes for seven days

Also known as: Dailies Total 1

delefilcon A/senofilcon A/ delfilcon A; senofilcon A/ delefilcon A/ senofilcon A

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 be appear able and willing to adhere to instruction set forth in this clinical protocol.
• The subject 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.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 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 any medication, which may interfere with contact lens wear.
• Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
• Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, PRK, 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 inflammatory event (e.g. past peripheral ulcer or round 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, multifocal, 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.
• Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (6)

Unknown Facility

Montgomery, Alabama, 36109, United States

Location

Unknown Facility

Jacksonville Beach, Florida, 32250, United States

Location

Unknown Facility

Longwood, Florida, 32779, United States

Location

Unknown Facility

Winter Park, Florida, 32792, United States

Location

Unknown Facility

Westerville, Ohio, 43081, United States

Location

Unknown Facility

Salem, Virginia, 24153, United States

Location

Results Point of Contact

• Title: John R. Buch, O.D., M.S., F.A.A.O.
• Organization: Johnson & Johnson Vision Care Inc.

JBUCH@its.jnj.com

904-443-3500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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 22, 2015
• First Posted: April 28, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 19, 2018
• Results First Posted: June 13, 2016

Record last verified: 2016-07

Locations

US (6)