Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

Refractive Error Clinical Trial

Official title:

Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349632
• Other study ID #: CLE383-C004
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: February 16, 2018

Study information

• Verified date: January 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Description:

The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 16, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and must sign an approved Informed Consent Form

• Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months

• Best Corrected Visual Acuity of 20/25 Snellen or better in each eye

• Willing to stop wearing habitual contact lenses for the duration of study participation

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.

• Routinely sleeps in habitual contact lenses

• Currently wears Oasys 1-Day, MyDay, or Moist contact lenses

• Other protocol-defined exclusion criteria may apply

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• verofilcon A contact lenses
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
• senofilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
• stenfilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
• etafilcon A contact lenses
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Johns Creek	Georgia
United States	Alcon Investigative Site	Maitland	Florida
United States	Alcon Investigative Site	Pensacola	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Quality of Vision	Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.	Day 8, each product

External Links

•   Results from the Novartis Clinical Trial Results Website