DAILIES TOTAL1® Lubricity Post Wear

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Delefilcon A contact lenses

• Registration Number: NCT02072980
• Lead Sponsor: Alcon Research

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Study Start: 2014-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-04
• Results First Submitted: 2015-04-27
• Results First Submitted QC: 2015-04-27
• Last Update Submitted: 2015-04-27
• Results First Posted: 2015-05-14
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
15mins/16hrs	Delefilcon A contact lenses	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.
16hrs/15mins	Delefilcon A contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn	Day 1 (for each period), 16 hours	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.

Secondary Outcome Measures

Name	Time	Method
Average Coefficient of Friction at 15 Minutes	Day 1 (for each period), 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.