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

Phase 4

Completed

• Conditions: Contact Lens Base Curve (BC) Fit and Comfort
• Interventions: Device: Contact Lenses with 8.5 BC; Device: Contact Lenses with 9.0 BC

• Registration Number: NCT02537522
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-01
• Results First Submitted: 2016-11-11
• Results First Submitted QC: 2016-11-11
• Results First Posted: 2017-01-10
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test/Control - Phase 1	Contact Lenses with 9.0 BC	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.
Control/Test - Phase 1	Contact Lenses with 8.5 BC	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.
Control/Test - Phase 2	Contact Lenses with 9.0 BC	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.
Test/Control - Phase 1	Contact Lenses with 8.5 BC	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.
Test/Control - Phase 2	Contact Lenses with 9.0 BC	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.
Control/Test - Phase 1	Contact Lenses with 9.0 BC	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.
Test/Control - Phase 2	Contact Lenses with 8.5 BC	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.
Control/Test - Phase 2	Contact Lenses with 8.5 BC	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.

Primary Outcome Measures

Name	Time	Method
Correlation Between Subjective CLUE Comfort and Keratometry	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.
Correlation Between Subjective CLUE Comfort and Corneal Diameter	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.