Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

FID123238

Systane Hydration

About this trial

This is an interventional other trial for Dry Eye focused on measuring Dry eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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

Key Exclusion Criteria:

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

Other protocol-specified inclusion/exclusion criteria may apply.

Sites / Locations

Alcon Investigator 8169

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline in comfort rating

A visual analogue scale will be used

Secondary Outcome Measures

Full Information

NCT ID

NCT04830956

First Posted

April 1, 2021

Last Updated

November 15, 2021

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT04830956

Brief Title

Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

Official Title

Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

June 30, 2021 (Actual)

Primary Completion Date

November 10, 2021 (Actual)

Study Completion Date

November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry eye

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

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.

Arm Title

Sequence 3

Arm Type

Experimental

Arm Description

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.

Arm Title

Sequence 4

Arm Type

Experimental

Arm Description

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.

Arm Title

Sequence 5

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

FID123238

Intervention Description

Lubricant applied to the ocular surface

Intervention Type

Other

Intervention Name(s)

Systane Hydration

Intervention Description

Drops applied to the ocular surface

Primary Outcome Measure Information:

Title

Change from baseline in comfort rating

Description

A visual analogue scale will be used

Time Frame

Baseline, up to 12 Hours (Day 1, each product)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Key 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 Key Exclusion Criteria: Has suffered any ocular injury to either eye in the past 12 weeks Is pregnant or lactating at the time of enrollment Other protocol-specified inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Lead, Dry Eye

Organizational Affiliation

Alcon Research, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Alcon Investigator 8169

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Dry Eye

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial