ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

Refractive Error Clinical Trial

Official title:

ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Clinical Comparison in a Symptomatic Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750813
• Other study ID #: CLV771-P001
• Status: Completed
• Phase: N/A
• Start date: April 27, 2016
• Est. completion date: August 17, 2016

Study information

• Verified date: August 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 the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: August 17, 2016
• Est. primary completion date: August 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must sign informed consent form;

• Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;

• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;

• Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;

• Cylinder equal or lower than -0.75D in both eyes;

• Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;

• Can be successfully fitted with both study lenses at Visit 1;

• Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

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

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

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

• Fitted with monovision;

• Prior refractive surgery;

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

• Pregnant or lactating;

• Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;

• Participation in any clinical study within 30 days of Visit 1;

• Current DT1 or AO1D lens wearer;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A contact lenses

• Senofilcon A contact lenses

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon, a Novartis Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14	Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.	Day 14, each product
Secondary	Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14	The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.	Day 14, each product

External Links

•   Results from the Novartis Clinical Trial Results Website