NCT04631796

Brief Summary

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

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

November 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

December 3, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 12, 2022

Completed
Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

28 days

First QC Date

November 11, 2020

Results QC Date

December 15, 2021

Last Update Submit

December 15, 2021

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 and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

    Dispense; Week 2 Follow-up

Study Arms (1)

LID020098

EXPERIMENTAL

Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses will be removed nightly for cleaning and disinfection.

Device: Lehfilcon A contact lensesDevice: Multipurpose disinfection solution

Interventions

Lehfilcon A contact lensesDEVICE

Silicone hydrogel contact lenses with investigational coating

Also known as: LID020098
LID020098
Multipurpose disinfection solutionDEVICE

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

Also known as: OPTI-FREE® RepleniSH®
LID020098

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 weekly/monthly 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.
  • Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
  • Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
  • Monovision or multifocal contact lens wear.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alcon Investigative Site

Orlando, Florida, 32803, United States

Location

Alcon Investigative Site

Bloomington, Illinois, 61704, United States

Location

Alcon Investigative Site

Powell, Ohio, 43065, 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

    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
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 17, 2020

Study Start

December 3, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 12, 2022

Results First Posted

January 12, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)