DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses

• Registration Number: NCT02517567
• Lead Sponsor: Alcon Research

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.

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 Timeline

• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-07
• Study Start: 2015-09-21
• Primary Completion: 2016-04-22
• Study Completion: 2016-04-22
• Results First Submitted: 2017-04-19
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-12
• Results First Posted: 2018-02-01
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 4	Delefilcon A contact lenses	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.
Sequence 2	Narafilcon A contact lenses	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.
Sequence 3	Narafilcon A contact lenses	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.
Sequence 3	Somofilcon A contact lenses	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.
Sequence 1	Delefilcon A contact lenses	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.
Sequence 1	Somofilcon A contact lenses	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.
Sequence 2	Somofilcon A contact lenses	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.
Sequence 3	Delefilcon A contact lenses	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.
Sequence 4	Narafilcon A contact lenses	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.
Sequence 4	Somofilcon A contact lenses	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.
Sequence 1	Narafilcon A contact lenses	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.
Sequence 2	Delefilcon A contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Tear Film Evaporation Rate	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.