DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

NCT02517567 | Completed Results

• 1 other identifier: CLT978-P001
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• Tear Film Evaporation Rate

  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

Study Arms (4)

Sequence 1

OTHER

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; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses

Sequence 2

OTHER

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; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses

Sequence 3

OTHER

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; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses

Sequence 4

OTHER

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; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses

Interventions

Delefilcon A contact lenses DEVICE

Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions

Also known as: DAILIES TOTAL1®

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Narafilcon A contact lenses DEVICE

Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions

Also known as: 1-DAY ACUVUE® TruEye®

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Somofilcon A contact lenses DEVICE

Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions

Also known as: clariti® 1 day

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr Global Brand Medical Affairs Lead, GCRA
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Clinical Trial Management

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: September 21, 2015
• Primary Completion: April 22, 2016
• Study Completion: April 22, 2016
• Last Updated: July 2, 2018
• Results First Posted: February 1, 2018

Record last verified: 2017-07