Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Refractive Ametropia Clinical Trial

Official title:

Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085328
• Other study ID #: CLL949-C010
• Status: Completed
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: March 26, 2021

Study information

• Verified date: May 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 675
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and sign an Informed Consent Form.
• Willing to attend all scheduled study visits as required per protocol.
• Willing and able to wear assigned study lenses as required per protocol.
• Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
• Manifest cylinder = 0.75 diopter (D) in each eye.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
• History of eye surgery, including refractive surgery.
• Currently pregnant or breast-feeding.
• Monovision contact lens wearers.
• Daily disposable contact lens wearers.
• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Refractive Ametropia
• Refractive Errors

Intervention

Device:
• LID015385 soft contact lenses
Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear
• Comfilcon A soft contact lenses
Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear

Locations

Country	Name	City	State
United States	Asheville Eye Associates, PLLC	Asheville	North Carolina
United States	Beaumont Family Eye Care	Beaumont	Texas
United States	VisionPoint Eye Center	Bloomington	Illinois
United States	North Spartanburg Eye Center	Boiling Springs	South Carolina
United States	Primary Eyecare Group, PC	Brentwood	Tennessee
United States	Optimum Vision Care	Brighton	Massachusetts
United States	Family EyeCare Center	Campbell	California
United States	Franklin Park Eye Center, PC	Franklin Park	Illinois
United States	Fraser Eye Care Center	Fraser	Michigan
United States	Winston Eye Care	Fullerton	California
United States	ProCare Vision Centers, Inc.	Granville	Ohio
United States	Vision One Eyecare	Katy	Texas
United States	OMEGA Vision Center PA, DBA Sabal Eye Care	Longwood	Florida
United States	East West Eye Institute	Los Angeles	California
United States	Kurata Eye Care Center	Los Angeles	California
United States	Kindred Optics at Maitland Vision Center	Maitland	Florida
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Mid Florida Eye Center, PA	Mount Dora	Florida
United States	Dr.Elsa Pao, O.D	Oakland	California
United States	Eola Eyes	Orlando	Florida
United States	Vision Health Institute	Orlando	Florida
United States	Visual Performance Center Research & Development	Pensacola	Florida
United States	Midwest Vision Care	Piqua	Ohio
United States	Kannarr Eye Care, LLC	Pittsburg	Kansas
United States	Alterman, Modi & Wolter	Poughkeepsie	New York
United States	EyeCare Professionals, Inc. DBA Insight Research Clinic, LLC	Powell	Ohio
United States	Rochester Ophthalmological Group, PC	Rochester	New York
United States	Tekwnai Vision Center, Inc	Saint Louis	Missouri
United States	Dawn M Rakich, OD	San Antonio	Texas
United States	Complete Family Vision Care	San Diego	California
United States	Gordon Schanzlin New Vision Institute	San Diego	California
United States	Westview Optometry	San Diego	California
United States	Golden Vision	Sarasota	Florida
United States	Advancing Vision Research, LLC	Smyrna	Tennessee
United States	Dr. Schwartz Optometrist and Associates	Sterling Heights	Michigan
United States	West Bay Eye Associates	Warwick	Rhode Island
United States	Advanced Eyecare Specialists	West Palm Beach	Florida
United States	Clarke EyeCare Center	Wichita Falls	Texas
United States	Fischer Laser Eye Center, LLC	Willmar	Minnesota
United States	Wyomissing Optometric Center	Wyomissing	Pennsylvania

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 was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.	Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
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 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 was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.	Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
Primary	Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)	Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).	Up to Month 12