DAILIES TOTAL1® Lubricity Post Wear

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02072980
• Collaborator: (none)
• Enrollment: 15
• Arms: 2
• Duration (Months): 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Delefilcon A contact lenses	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

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®

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02072980
• Other Study ID Numbers: M-14-002
• First Posted: Feb 27, 2014
• Last Update Posted: May 14, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Alcon Research: DT1; DAILIES TOTAL1®; Lubricity
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 study center located in the US.
Pre-assignment Detail	This reporting group includes all randomized participants (15).

Arm/Group Title	16hr/15min	15min/16hr
Arm/Group Description	Delefilcon A contact lenses worn bilaterally 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.	Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
Period Title: Period 1, First Wear
STARTED	7	8
COMPLETED	7	8
NOT COMPLETED	0	0
Period Title: Period 1, First Wear
STARTED	7	8
COMPLETED	7	7
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Delefilcon A contact lenses worn during Period 1 and Period 2
Overall Participants	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.9 (10.91)
Sex: Female, Male (Count of Participants)
Female	9 60%
Male	6 40%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants who completed the study.

Arm/Group Title	16 Hours	Unworn
Arm/Group Description	Delefilcon A contact lenses worn for 16 hours in Period 1 or 2	Unworn delefilcon A contact lenses removed from the commercial packaging and soaked overnight in phosphate buffered saline
Measure Participants	14	14
Mean (Standard Deviation) [unitless]	0.0394 (0.0015)	0.0396 (0.0027)

2. Secondary Outcome

Title	Average Coefficient of Friction at 15 Minutes
Description	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.
Time Frame	Day 1 (for each period), 15 minutes

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants who completed the study.

Arm/Group Title	15 Minutes
Arm/Group Description	Delefilcon A contact lenses worn for 15 minutes during Period 1 or 2
Measure Participants	14
Mean (Standard Deviation) [unitless]	0.0392 (0.0017)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (March 2014 - April 2014). This analysis population includes all participants exposed to the investigational product, based on treatment-specific exposure.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained as solicited comments from the study participants and as observations by the Investigator.
Arm/Group Title	DAILIES TOTAL1
Arm/Group Description	Delefilcon A contact lenses worn during Period 1 and Period 2
All Cause Mortality
	DAILIES TOTAL1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DAILIES TOTAL1
	Affected / at Risk (%)	# Events
Total	0/15 (0%)
Other (Not Including Serious) Adverse Events
	DAILIES TOTAL1
	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)
Eye disorders
Corneal infiltrates	1/15 (6.7%)
Ocular discomfort	1/15 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.