DAILIES TOTAL1® Lubricity Post Wear

NCT ID: NCT02072980

Last Updated: 2015-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Delefilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses

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.

Group Type: OTHER

Delefilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses

Interventions

Delefilcon A contact lenses

Silicone hydrogel contact lenses

Intervention Type: DEVICE

Other Intervention Names

DAILIES TOTAL1®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa L. Zoota, MPH, CCRA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-14-002

Identifier Type: -

Identifier Source: org_study_id