DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

Refractive Error Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517567
• Other study ID #: CLT978-P001
• Status: Completed
• Phase: N/A
• Start date: September 21, 2015
• Est. completion date: April 22, 2016

Study information

• Verified date: July 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 22, 2016
• Est. primary completion date: April 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Delefilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
• Narafilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
• Somofilcon A contact lenses
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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