Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Refractive Errors Clinical Trial

Official title:

Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920280
• Other study ID #: CLL949-C009
• Status: Completed
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: October 5, 2019

Study information

• Verified date: July 2022
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Description:

Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 5, 2019
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.

• Manifest cylinder = 0.75 diopter (D) in each eye.

• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• 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.

• Monovision contact lens wearers.

• Habitually wearing Biofinity® lenses.

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• LID015385 contact lenses
Investigational silicone hydrogel contact lenses
• Comfilcon A soft contact lenses
Commercially available silicone hydrogel contact lenses
• CLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting system

Locations

Country	Name	City	State
United States	Alcon Investigator 3950	Bloomington	Illinois
United States	Alcon Investigator 6565	Maitland	Florida
United States	Alcon Investigator 6353	Memphis	Tennessee
United States	Alcon Investigator 6355	Orlando	Florida
United States	Alcon Investigator 6291	Pensacola	Florida
United States	Alcon Investigator 6567	Pittsburg	Kansas
United States	Alcon Investigator 6313	Powell	Ohio
United States	Alcon Investigator 6401	Warwick	Rhode Island

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) With Study Lenses - Completed Eyes	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.	Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)
Primary	Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.	Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)