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Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LID015385 contact lenses
Comfilcon A soft contact lenses
CLEAR CARE
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring Contact Lens, Daily Wear, Vision Correction

Eligibility Criteria

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

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.

Sites / Locations

  • Alcon Investigator 6565
  • Alcon Investigator 6355
  • Alcon Investigator 6291
  • Alcon Investigator 3950
  • Alcon Investigator 6567
  • Alcon Investigator 6313
  • Alcon Investigator 6401
  • Alcon Investigator 6353

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LID015385

Biofinity

Arm Description

LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.

Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2019
Last Updated
July 22, 2022
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03920280
Brief Title
Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens
Official Title
Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
October 5, 2019 (Actual)
Study Completion Date
October 5, 2019 (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
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Contact Lens, Daily Wear, Vision Correction

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
LID015385
Arm Type
Experimental
Arm Description
LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.
Arm Title
Biofinity
Arm Type
Active Comparator
Arm Description
Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.
Intervention Type
Device
Intervention Name(s)
LID015385 contact lenses
Intervention Description
Investigational silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
Comfilcon A soft contact lenses
Other Intervention Name(s)
Biofinity
Intervention Description
Commercially available silicone hydrogel contact lenses
Intervention Type
Device
Intervention Name(s)
CLEAR CARE
Intervention Description
Hydrogen peroxide-based cleaning and disinfecting system
Primary Outcome Measure Information:
Title
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
Description
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.
Time Frame
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)
Title
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CDMA Project Lead, Vision Care
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 6565
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Alcon Investigator 6355
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Alcon Investigator 6291
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Alcon Investigator 3950
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Alcon Investigator 6567
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Alcon Investigator 6313
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States
Facility Name
Alcon Investigator 6401
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02888
Country
United States
Facility Name
Alcon Investigator 6353
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 Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

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