DAILIES TOTAL1® Lubricity Post Wear

NCT02072980 | Completed Results

• 1 other identifier: M-14-002
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Keywords

DT1; DAILIES TOTAL1®; Lubricity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Average Coefficient of Friction at 15 Minutes

  Day 1 (for each period), 15 minutes

Study Arms (2)

16hrs/15mins

OTHER

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

15mins/16hrs

OTHER

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

Interventions

Delefilcon A contact lenses DEVICE

Silicone hydrogel contact lenses

Also known as: DAILIES TOTAL1®

15mins/16hrs; 16hrs/15mins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Cecile Maissa, Global Brand Medical Affairs Lead - Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Lisa L. Zoota, MPH, CCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 27, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 14, 2015
• Results First Posted: May 14, 2015

Record last verified: 2015-04