Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

• ClinicalTrials.gov Identifier: NCT02537522
• Recruitment Status: Completed
• First Posted: September 1, 2015
• Results First Posted: January 10, 2017
• Last Update Posted: July 11, 2017
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.

Condition or disease	Intervention/treatment	Phase
Contact Lens Base Curve (BC) Fit and Comfort	Device: Contact Lenses with 8.5 BC; Device: Contact Lenses with 9.0 BC	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Actual Study Start Date: July 1, 2015
• Actual Primary Completion Date: July 1, 2015
• Actual Study Completion Date: July 1, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Test/Control - Phase 1; Over visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner.	Device: Contact Lenses with 8.5 BC; Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.; Other Name: Marketed Daily Disposable Soft Contact Lenses; Device: Contact Lenses with 9.0 BC; Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.; Other Name: Marketed Daily Disposable Soft Contact Lenses
Experimental: Control/Test - Phase 1; Over visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner.	Device: Contact Lenses with 8.5 BC; Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.; Other Name: Marketed Daily Disposable Soft Contact Lenses; Device: Contact Lenses with 9.0 BC; Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.; Other Name: Marketed Daily Disposable Soft Contact Lenses
Experimental: Test/Control - Phase 2; During Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner.	Device: Contact Lenses with 8.5 BC; Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.; Other Name: Marketed Daily Disposable Soft Contact Lenses; Device: Contact Lenses with 9.0 BC; Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.; Other Name: Marketed Daily Disposable Soft Contact Lenses
Experimental: Control/Test - Phase 2; During Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner.	Device: Contact Lenses with 8.5 BC; Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.; Other Name: Marketed Daily Disposable Soft Contact Lenses; Device: Contact Lenses with 9.0 BC; Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.; Other Name: Marketed Daily Disposable Soft Contact Lenses

Outcome Measures

Primary Outcome Measures :

1. Correlation Between Subjective CLUE Comfort and Keratometry [ Time Frame: 3-day follow-up ]
   CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.
2. Correlation Between Subjective CLUE Comfort and Corneal Diameter [ Time Frame: 3-day follow-up ]
   Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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 no less than 18 and no more than 45 years of age with no presbyopic add.
• The subject must be willing and able to adhere to the instructions set out in the protocol.
• The subject must be an adapted soft contact lens wearer in both eyes.
• The subject must be willing to wear the study contact lenses up to 14 hours/day.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
• The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
• The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
• The subject must require a visual correction in both eyes (no monofit or monovision allowed).
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

• Current 1-DAY ACUVUE® TruEye® wearers
• Anisometropia of 1.00 D or greater
• Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
• Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
• 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 ocular infection
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
• Pregnancy or lactation
• Diabetes
• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Contacts and Locations

Locations

United States, Florida

Jacksonville, Florida, United States, 32205

Jacksonville, Florida, United States, 32256

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02537522 History of Changes
• Other Study ID Numbers: CR-5730
• First Posted: September 1, 2015
• Results First Posted: January 10, 2017
• Last Update Posted: July 11, 2017
• Last Verified: June 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No