DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

May 31, 2018 updated by: Alcon Research

Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids

The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Sign an informed consent document;
  • Adapted, current soft contact lens wearer;
  • Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
  • Can be successfully fitted with study lenses;
  • Willing to wear lenses for a minimum of 8 hours prior to each study visit;
  • Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
  • Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
  • Monocular (only 1 eye with functional vision) or fit with only one lens;
  • History of herpetic keratitis, ocular surgery, or irregular cornea;
  • Known pregnancy and lactation;
  • Other protocol-specified exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence 1
Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • DAILIES TOTAL1®
Device: Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • 1-DAY ACUVUE® TruEye®
Device: Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • clariti® 1 day
Other: Sequence 2
Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • DAILIES TOTAL1®
Device: Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • 1-DAY ACUVUE® TruEye®
Device: Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • clariti® 1 day
Other: Sequence 3
Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • DAILIES TOTAL1®
Device: Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • 1-DAY ACUVUE® TruEye®
Device: Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • clariti® 1 day
Other: Sequence 4
No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Device: Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • DAILIES TOTAL1®
Device: Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • 1-DAY ACUVUE® TruEye®
Device: Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Other Names:
  • clariti® 1 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear Film Evaporation Rate
Time Frame: Day 1, Hour 8, each product
Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Day 1, Hour 8, each product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Manager, Clinical Trial Management, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2015

Primary Completion (Actual)

April 22, 2016

Study Completion (Actual)

April 22, 2016

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLT978-P001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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