NCT04963543

Brief Summary

The purpose of this study is to evaluate the comfort of an ocular lubricant in symptomatic contact lens wearers. This study will be conducted in Canada.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 6, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

July 22, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

July 6, 2021

Last Update Submit

November 2, 2021

Conditions

Ocular Comfort

Keywords

Contact Lenses

Outcome Measures

Primary Outcomes (1)

  • Comfort, collected for each eye

    A visual analogue scale will be used

    Up to Day 6

Study Arms (1)

FID123238

EXPERIMENTAL

FID123238 applied to the ocular surface, 1 application per day, for five consecutive days

Other: FID123238

Interventions

FID123238OTHER

Lubricant applied to the ocular surface

FID123238

Eligibility Criteria

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

You may qualify if:

  • Is able to understand and sign an approved information consent letter;
  • Habitually wears daily disposable soft contact lenses in both eyes;
  • Is able to achieve 20/40 or better monocular VA with habitual contact lenses;
  • Has a pair of spectacles for vision correction.

You may not qualify if:

  • Routinely sleeps in habitual contact lenses;
  • Has any known active ocular disease and/or infection;
  • Is pregnant or lactating;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Investigative Site 6189

Waterloo, Ontario, N2L 3G1, Canada

Location

Study Officials

  • Clinical Trial Lead, Dry Eye

    Alcon Research, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 15, 2021

Study Start

July 22, 2021

Primary Completion

October 29, 2021

Study Completion

October 29, 2021

Last Updated

November 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)