DAILIES TOTAL1® Lens Centration in a Japanese Population

Pilot Evaluation of DAILIES TOTAL1® Lens Centration in a Japanese Population

The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Myopia
• Intervention / Treatment: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Contact Alcon Japan Ltd. for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sign Informed Consent document.
• Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
• Symptoms of contact lens discomfort as defined by protocol.
• Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
• Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
• Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
• Acceptable contact lens fit with both study contact lenses.
• Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Currently wearing DT1 or 1DAVTE.
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
• Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
• Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
• History of herpetic keratitis, ocular surgery or irregular cornea.
• Prior refractive surgery (e.g. LASIK, PRK, etc).
• Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
• Judged ineligible as a patient in this clinical study by the investigator.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DT1, then 1DAVTE; Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.	Device: Delefilcon A contact lenses; Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear; Other Names: DAILIES TOTAL1®; Device: Narafilcon A contact lenses; Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear; Other Names: 1-DAY ACUVUE® TruEye®
Other: 1DAVTE, then DT1; Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.	Device: Delefilcon A contact lenses; Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear; Other Names: DAILIES TOTAL1®; Device: Narafilcon A contact lenses; Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear; Other Names: 1-DAY ACUVUE® TruEye®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of Lens Centration After 7 ± 2 Days of Wear	Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.	Day 7, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Senior Manager, Clinical Development, Alcon Japan, Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: September 29, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: December 24, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Myopia; Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: ALJ-V2014-1