Lubricity Post-Wear - Competitive Lenses Pilot

Refractive Error Clinical Trial

Official title:

Lubricity Post-Wear - Pilot Evaluation of Daily Disposable Silicone Hydrogel Contact Lenses After Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402127
• Other study ID #: CLT567-P001
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: August 3, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure the coefficient of friction of three silicone hydrogel daily disposable contact lenses (1-DAY ACUVUE® TruEye®, MyDay™ and clariti® 1day) after 16 hours of wear.

Description:

In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must sign an informed consent form.

• Soft contact lens wearer (both eyes).

• Willing to wear study lenses at least 16 waking hours and attend all 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.

• Use of artificial tears and rewetting drops during the study.

• Monocular (only 1 eye with functional vision) or fit with only 1 lens.

• History of herpetic keratitis, ocular surgery, or irregular cornea.

• Pregnant.

• Other protocol-specified exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Narafilcon A contact lenses
Silicone hydrogel contact lenses, worn and unworn
• Somofilcon A contact lenses
Silicone hydrogel contact lenses, worn and unworn
• Stenfilcon A contact lenses
Silicone hydrogel contact lenses, worn and unworn

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Coefficient of Friction (CF) for worn lenses at 16 hours (CF16)	Worn contact lenses will be removed from the participant's eye and the CF will be measured. A lower CF may indicate higher contact lens lubricity.	Day 1, after 16 hours of wear	No
Secondary	Average Coefficient of Friction (CF) for unworn lenses (CFuw)	Unworn contact lenses will be removed from the commercial packaging and the CF of the unworn lenses will be measured. A lower CF may indicate higher contact lens lubricity.	Up to Month 3	No