Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

• ClinicalTrials.gov Identifier: NCT01484054
• Recruitment Status: Completed
• First Posted: December 2, 2011
• Results First Posted: January 20, 2014
• Last Update Posted: June 19, 2018
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

Condition or disease	Intervention/treatment	Phase
Refractive Ametropia	Device: etafilcon A with print and PVP for dark eyes (EAPVPDE); Device: etafilcon A control lens (EADE)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes
• Study Start Date: November 2011
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Arms and Interventions

Arm	Intervention/treatment
EAPVPDE/EADE; etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.	Device: etafilcon A with print and PVP for dark eyes (EAPVPDE); A daily disposable contact lens; Device: etafilcon A control lens (EADE); A marketed daily disposable contact lens
EADE/EAPVPDE; etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.	Device: etafilcon A with print and PVP for dark eyes (EAPVPDE); A daily disposable contact lens; Device: etafilcon A control lens (EADE); A marketed daily disposable contact lens

Outcome Measures

Primary Outcome Measures :

1. Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire [ Time Frame: After 7 to 9 days of lens wear ]
   The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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 from 0-120.
2. Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire [ Time Frame: After 7 to 9 days of lens wear ]
   The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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.
3. Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire [ Time Frame: After 7 to 9 days of lens wear ]
   The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 34 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
• The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
• The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
• The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
• The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
• The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
• Any cylinder power must be:<=0.75D.
• The subject must have visual acuity best correctable to 20/25 or better for each eye.
• The subject must have normal eyes (no ocular medications or ocular infection of any type).
• The subject must read and sign the Statement of Informed Consent.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.
• Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
• Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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 ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Any color deficiencies (color blindness) - to the best of the subject's knowledge.
• Pregnancy or lactation.
• Diabetes.
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• Habitual contact lens type is toric, multifocal, or is worn as extended wear.
• Subject presents with one dark iris color and one light iris color
• Subject has heterochromia iridis (a difference in color between parts of one iris)
• The subject is an employee or family member of the clinical study site.

Contacts and Locations

Locations

United States, Connecticut

Bloomfield, Connecticut, United States, 06002

United States, Florida

Tallahassee, Florida, United States, 32308

United States, Kansas

Overland Park, Kansas, United States, 66207

United States, New York

Jamestown, New York, United States, 14750

United States, Pennsylvania

Kingston, Pennsylvania, United States, 18704

Moon, Pennsylvania, United States, 15108

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT01484054
• Other Study ID Numbers: CR-005128
• First Posted: December 2, 2011
• Results First Posted: January 20, 2014
• Last Update Posted: June 19, 2018
• Last Verified: May 2015

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases