DAILIES TOTAL1® Lubricity Post Wear

Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear

The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.

Study Overview

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

Detailed Description

In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willing and able to sign Informed Consent document.
• Adapted, current soft contact lens wearer.
• Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.
• Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.
• Vision correctable to 20/25 or better in each eye at distance with study lenses.
• Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.
• Able to be successfully fitted with study lenses.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.
• Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
• Use of artificial tears and rewetting drops during the study.
• Monocular (only one eye with functional vision) or fit with only one lens.
• Any abnormal ocular condition observed during the Visit 1 slit lamp examination.
• History of herpetic keratitis, ocular surgery, or irregular cornea.
• Pregnant.
• Participation in any clinical study within 30 days of Visit 1.
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 16hrs/15mins; Delefilcon A contact lenses worn bilaterally (in both eyes) for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.	Device: Delefilcon A contact lenses; Silicone hydrogel contact lenses; Other Names: DAILIES TOTAL1®
Other: 15mins/16hrs; Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, followed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.	Device: Delefilcon A contact lenses; Silicone hydrogel contact lenses; Other Names: DAILIES TOTAL1®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn	Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.	Day 1 (for each period), 16 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Coefficient of Friction at 15 Minutes	Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.	Day 1 (for each period), 15 minutes

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Lisa L. Zoota, MPH, CCRA, Alcon Research

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 27, 2014

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Lubricity; DT1; DAILIES TOTAL1®
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: M-14-002