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Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LID014341 contact lenses
Comfilcon A contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LID014341

Biofinity

Arm Description

LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis

Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2018
Last Updated
June 7, 2021
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03586167
Brief Title
Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
Official Title
Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 27, 2018 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LID014341
Arm Type
Experimental
Arm Description
LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis
Arm Title
Biofinity
Arm Type
Active Comparator
Arm Description
Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis
Intervention Type
Device
Intervention Name(s)
LID014341 contact lenses
Intervention Description
Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating
Intervention Type
Device
Intervention Name(s)
Comfilcon A contact lenses
Other Intervention Name(s)
BIOFINITY©
Intervention Description
Silicone hydrogel contact lenses
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA)
Description
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.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Research
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigative Site
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
Alcon Investigative Site
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Alcon Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

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