DAILIES TOTAL1® Lubricity Post Wear

Refractive Error Clinical Trial

Official title:

Evaluation of the Lubricity of DAILIES TOTAL1® Contact Lenses After Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072980
• Other study ID #: M-14-002
• Status: Completed
• Phase: N/A
• First received: February 24, 2014
• Last updated: April 27, 2015
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: April 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 primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.

Description:

In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to sign Informed Consent document.

• Adapted, current soft contact lens wearer.

• Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D.

• Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction.

• Vision correctable to 20/25 or better in each eye at distance with study lenses.

• Willing to wear study lenses at least 16 waking hours in one day and attend all study visits.

• Able to be successfully fitted with study lenses.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator.

• Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.

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

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

• Any abnormal ocular condition observed during the Visit 1 slit lamp examination.

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

• Pregnant.

• Participation in any clinical study within 30 days of Visit 1.

• 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:
• Delefilcon A contact lenses
Silicone hydrogel contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn	Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.	Day 1 (for each period), 16 hours	No
Secondary	Average Coefficient of Friction at 15 Minutes	Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.	Day 1 (for each period), 15 minutes	No