Systane Complete Multi-symptom Relief

NCT ID: NCT05056155

Last Updated: 2022-03-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-09

Study Completion Date

2022-03-25

Brief Summary

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The purpose of this study is to demonstrate effective symptom relief with the use of Systane Complete among subjects with dry eye disease (DED).

Detailed Description

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Subjects will be expected to attend a screening/baseline visit and one additional visit at Day 28 (± 2 days), with a telephone call visit conducted at Day 14 (± 2 days). Individual duration of subject participation will be approximately 28 days.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Systane Complete

First dose of Systane Complete in both eyes on Day 0, followed by Systane Complete self-administered 4 times daily for 28 days

Group Type EXPERIMENTAL

Systane Complete

Intervention Type OTHER

Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film

Interventions

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Systane Complete

Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film

Intervention Type OTHER

Other Intervention Names

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Systane® Complete Lubricant Eye Drops

Eligibility Criteria

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Inclusion Criteria

* Able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form.
* Willing and able to attend all study visits as required per protocol.
* Have dry eye symptoms as specified in the protocol.
* Willing to discontinue use of all habitual artificial tear supplements for the entire study duration.

Exclusion Criteria

* Ocular conditions as specified in the protocol.
* Contact lens use within one week prior to screening visit.
* Use of medications as specified in the protocol.
* Pregnant or breast feeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Lead, Ocular Health

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Alcon Investigator 1455

Kansas City, Missouri, United States

Site Status

Alcon Investigator 8046

Granville, Ohio, United States

Site Status

Alcon Investigator 6313

Powell, Ohio, United States

Site Status

Alcon Investigator 8175

Austin, Texas, United States

Site Status

Countries

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United States

References

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Bickle K, Miller JR, Tauber J, Awisi-Gyau D. Multi-symptom Relief with Propylene Glycol-Hydroxypropyl-Guar Nanoemulsion Lubricant Eye Drops in Subjects with Dry Eye Disease: A Post-Marketing Prospective Study. Ophthalmol Ther. 2024 Feb;13(2):481-494. doi: 10.1007/s40123-023-00853-3. Epub 2023 Dec 11.

Reference Type DERIVED
PMID: 38079084 (View on PubMed)

Other Identifiers

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DEC262-P002

Identifier Type: -

Identifier Source: org_study_id

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