Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518008
• Other study ID #: CLE383-C006
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: June 11, 2018

Study information

• Verified date: March 2019
• 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 overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 11, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Understand and sign an Informed Consent Form;

• Successful wear of 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 (BCVA) 20/25 or better in each eye;

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

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Anterior segment infection, inflammation, or abnormality or disease that contraindicates 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;

• Refractive, ocular, or intraocular surgery, as specified in the protocol;

• Eye condition or injury, as specified in the protocol;

• Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;

• Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;

• Currently wearing clariti® 1 day contact lenses;

• Habitually wearing monovision or multifocal lenses during the last 3 months;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

Device:
• verofilcon A contact lenses
Investigational daily disposable soft contact lenses
• somofilcon A contact lenses
Commercially available daily disposable soft contact lenses

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Maitland	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 measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.	Day 8, each product

External Links

•   Results from the Novartis Clinical Trial Results Website