Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use

NCT02394756 | Completed Results

• 1 other identifier: CR-5615
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users.

Conditions

Visual Performance

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. Scores range 0-120.

  1-Day Follow-up

• Subjective Overall Quality of Vision

  Subjective Overall quality of vision 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. Scores range 0-120.

  1-Day Follow-up

Study Arms (3)

Marketed Soft Contact Lens (Test)

EXPERIMENTAL

Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type.

Device: Marketed Soft Contact lens; Device: AIR OPTIX® AQUA; Device: Biofinity®

AIR OPTIX® AQUA

ACTIVE COMPARATOR

Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type.

Device: Marketed Soft Contact lens; Device: AIR OPTIX® AQUA; Device: Biofinity®

Biofinity®

ACTIVE COMPARATOR

Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type.

Device: Marketed Soft Contact lens; Device: AIR OPTIX® AQUA; Device: Biofinity®

Interventions

Marketed Soft Contact lens DEVICE

Replacement schedule every 2 weeks

Also known as: senofilcon A

AIR OPTIX® AQUA; Biofinity®; Marketed Soft Contact Lens (Test)

AIR OPTIX® AQUA DEVICE

Replacement schedule every 4 weeks

Also known as: lotrafilcon B

AIR OPTIX® AQUA; Biofinity®; Marketed Soft Contact Lens (Test)

Biofinity® DEVICE

Replacement schedule every 4 weeks

Also known as: comfilcon A

AIR OPTIX® AQUA; Biofinity®; Marketed Soft Contact Lens (Test)

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 be between 18 and 40 years of age.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -8.00D in each eye.
• The subject's refractive cylinder must be no more than -1.25 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, smartphones, 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 subjects 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 by keratometry.
• Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, 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 abnormality or strabismus.
• Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Unknown Facility

Waterloo, Ontario, N2I3G1, 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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 19, 2018
• Results First Posted: April 25, 2017

Record last verified: 2017-03

Locations

CA (1)