NCT05741216

Brief Summary

The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.

Trial Health

90
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 May 2023

Shorter than P25 for not_applicable

Geographic Reach
2 countries

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

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

February 14, 2023

Last Update Submit

October 10, 2023

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Ocular comfort

    Comfort will be rated using a visual analog scale (0-100) from 0-100, where 0=poor and 100=excellent.

    Up to Day 5

Study Arms (4)

OTF Test 1

EXPERIMENTAL

One application of ocular lubricant to each eye at night for 5 consecutive nights

Other: OTF Ocular Lubricant

OTF Test 2

EXPERIMENTAL

One application of ocular lubricant to each eye at night for 5 consecutive nights

Other: OTF Ocular Lubricant

OTF Test 3

EXPERIMENTAL

One application of ocular lubricant to each eye at night for 5 consecutive nights

Other: OTF Ocular Lubricant

Ocular lubricant

ACTIVE COMPARATOR

One drop of ocular lubricant applied to each eye at night for 5 consecutive nights

Other: Ocular Lubricant

Interventions

OTF Ocular LubricantOTHER

Ocular lubricant in 1 of 3 test formulations

OTF Test 1OTF Test 2OTF Test 3
Ocular LubricantOTHER

Commercially available ocular lubricant

Also known as: SYSTANE™ Gel, Genteal™ Gel
Ocular lubricant

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
  • Uses rewetting drops on a regular basis;

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 (3)

School of Optometry and Vision

Sydney, New South Wales, 2052, Australia

Location

Deakin Collaborative Eye Care Clinic, Deakin University

Waurn Ponds, Victoria, 3216, Australia

Location

School of Optometry and Vision Science, University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Clinical Trial Lead, Dry Eye

    Alcon Research, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 23, 2023

Study Start

May 1, 2023

Primary Completion

October 2, 2023

Study Completion

October 2, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)AU(2)