Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Refractive Errors Clinical Trial

Official title:

Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586167
• Other study ID #: CLY935-C004
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: September 27, 2018

Study information

• Verified date: June 2021
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 27, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and sign an informed consent form approved by an Institutional review board (IRB);

• Successful wear of spherical monthly replacement 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.

Exclusion Criteria:

• Any conditions or use of medications that could contraindicate contact lens wear;

• History of or plan to have refractive surgery in either eye;

• Irregular cornea in either eye;

• Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;

• 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;

• Habitual Biofinity contact lens wearers.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• LID014341 contact lenses
Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating
• Comfilcon A contact lenses
Silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Bloomington	Illinois
United States	Alcon Investigative Site	Johns Creek	Georgia
United States	Alcon Investigative Site	Maitland	Florida
United States	Alcon Investigative Site	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Visual Acuity (VA)	VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.	Day 30