DAILIES TOTAL1® Lens Centration in a Japanese Population

NCT02252133 | Completed Results

• 1 other identifier: ALJ-V2014-1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia; Refractive Error

Keywords

Contact lenses; Myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DT1, then 1DAVTE

OTHER

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; Device: Narafilcon A contact lenses

1DAVTE, then DT1

OTHER

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; Device: Narafilcon A contact lenses

Interventions

Delefilcon A contact lenses DEVICE

Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Also known as: DAILIES TOTAL1®

1DAVTE, then DT1; DT1, then 1DAVTE

Narafilcon A contact lenses DEVICE

Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear

Also known as: 1-DAY ACUVUE® TruEye®

1DAVTE, then DT1; DT1, then 1DAVTE

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Japan Ltd. for Trial Locations

Tokyo, Japan

Location

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Senior Manager, Clinical Development, Japan
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Senior Manager, Clinical Development

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 29, 2016
• Results First Posted: December 28, 2015

Record last verified: 2015-11

Locations

JP (1)