MedDataX Logo

Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

NCT ID: NCT04830956

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-11-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dry eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sequence 1

FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

Group Type EXPERIMENTAL

FID123238

Intervention Type OTHER

Lubricant applied to the ocular surface

Systane Hydration

Intervention Type OTHER

Drops applied to the ocular surface

Sequence 2

FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

Group Type EXPERIMENTAL

FID123238

Intervention Type OTHER

Lubricant applied to the ocular surface

Systane Hydration

Intervention Type OTHER

Drops applied to the ocular surface

Sequence 3

FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

Group Type EXPERIMENTAL

FID123238

Intervention Type OTHER

Lubricant applied to the ocular surface

Systane Hydration

Intervention Type OTHER

Drops applied to the ocular surface

Sequence 4

FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

Group Type EXPERIMENTAL

FID123238

Intervention Type OTHER

Lubricant applied to the ocular surface

Systane Hydration

Intervention Type OTHER

Drops applied to the ocular surface

Sequence 5

FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.

Group Type EXPERIMENTAL

FID123238

Intervention Type OTHER

Lubricant applied to the ocular surface

Systane Hydration

Intervention Type OTHER

Drops applied to the ocular surface

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FID123238

Lubricant applied to the ocular surface

Intervention Type OTHER

Systane Hydration

Drops applied to the ocular surface

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Able to understand and sign an information consent letter
* Willing and able to follow instructions and maintain the appointment schedule
* Has dry eye symptoms

Exclusion Criteria

* Has suffered any ocular injury to either eye in the past 12 weeks
* Is pregnant or lactating at the time of enrollment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trial Lead, Dry Eye

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alcon Investigator 8169

Carlton, Victoria, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DEJ475-E004

Identifier Type: -

Identifier Source: org_study_id