Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

Refractive Error Clinical Trial

Official title:

Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710292
• Other study ID #: CLS104-P001
• Status: Completed
• Phase: N/A
• Start date: April 25, 2016
• Est. completion date: September 14, 2016

Study information

• Verified date: May 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 14, 2016
• Est. primary completion date: September 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Must sign an informed consent form;

• Habitual current daily disposable soft contact lenses wearer;

• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;

• Lenses within the power range specified in the protocol;

• Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;

• Acceptable lens fit with both study contact lenses;

• Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Currently wearing DT1 or TE sphere lenses;

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;

• Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;

• Eye injury or surgery within 12 weeks immediately prior to enrollment;

• History of herpetic keratitis, ocular surgery or irregular cornea;

• Prior refractive surgery;

• Monocular (only 1 eye with functional vision) or fit with only 1 lens;

• Participation in any clinical trial within 30 days of the enrollment visit;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A contact lenses

• Narafilcon A contact lenses

Locations

Country	Name	City	State
Japan	Contact Alcon Japan, Ltd. for Trial Locations	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear	Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.	Day 10, each product

External Links

•   Results from the Novartis Clinical Trial Results Website