Clinical Evaluation of Two Monthly Contact Lenses

Refractive Errors Clinical Trial

Official title:

Clinical Evaluation of Two Monthly Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459131
• Other study ID #: CLD523-E001
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: March 26, 2018

Study information

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

Clinical Trial Summary

The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Able to understand and sign an approved informed consent form (ICF);

• Successful wear of BIOFINITY® (spherical) (or private label) 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;

• Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);

• Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated;

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

• Current or history of eye injury or disorders, as specified in the protocol;

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

• Habitual contact lens wear 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 that would require instillation during contact lens wear;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Comfilcon A with Digital Zone Optics™ contact lenses
Silicone hydrogel spherical contact lenses with Digital Zone Optics™
• Comfilcon A contact lenses
Silicone hydrogel spherical 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	Subjective Rating of Overall Vision	Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.	Day 7, each product
Secondary	Over-refraction	Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.	Day 1 (Dispense), each product

External Links

•   Results from the Novartis Clinical Trial Results Website