NCT04702984

Brief Summary

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 8, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

January 8, 2021

Results QC Date

February 10, 2022

Last Update Submit

March 8, 2022

Conditions

Refractive Errors

Keywords

VisionContact lenses

Outcome Measures

Primary Outcomes (1)

  • Front Surface Wettability, by Category

    Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

    Dispense; Week 1 Follow-up

Study Arms (1)

LID021201

EXPERIMENTAL

LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.

Device: LID021201 contact lensesDevice: OPTI-FREE multipurpose solution

Interventions

LID021201 contact lensesDEVICE

Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear

LID021201
OPTI-FREE multipurpose solutionDEVICE

Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Also known as: OPTI-FREE® RepleniSH®
LID021201

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
  • Successful wear of spherical daily wear frequent 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.
  • Willing to stop wearing habitual contact lenses for the duration of study participation.

You may not qualify if:

  • Any condition that contraindicates contact lens wear, as determined by the Investigator.
  • Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
  • History of refractive surgery or plan to have refractive surgery during the study.
  • Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
  • Wears 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alcon Investigator 6565

Maitland, Florida, 32751, United States

Location

Alcon Investigator 6353

Memphis, Tennessee, 38111, United States

Location

Alcon Investigator 8028

Wichita Falls, Texas, 76308, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
CDMA Project Lead, Vision Care
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sr. Clinical Trial Lead, CDMA Vision Care

    Alcon Research, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Lens will be provided with investigational product labeling
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 11, 2021

Study Start

January 21, 2021

Primary Completion

February 26, 2021

Study Completion

February 26, 2021

Last Updated

March 16, 2022

Results First Posted

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)