Systane Hydration in Subjects Undergoing Cataract Surgery

NCT ID: NCT05056233

Last Updated: 2023-02-22

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-01-12

Brief Summary

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The primary objective of this study is to demonstrate reduced corneal staining with use of Systane Hydration among subjects with dry eye disease (DED) undergoing routine cataract removal and monofocal intraocular lens (IOL) implantation.

Detailed Description

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Subjects will attend 6 scheduled study visits for an individual duration of participation of 6 weeks. One eye (study eye) will be followed.

Conditions

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Dry Eye Disease Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Systane Hydration

Systane Hydration lubricant eye drops dosed 4 times a day for 6 weeks (2 weeks prior to surgery and 4 weeks post surgery), with investigator defined post-operative standard of care

Group Type EXPERIMENTAL

Systane Hydration lubricant eye drops

Intervention Type OTHER

Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye

No Treatment

Investigator defined post-operative standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Systane Hydration lubricant eye drops

Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye

Intervention Type OTHER

Other Intervention Names

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Systane Hydration® Ophthalmic Solution

Eligibility Criteria

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Inclusion Criteria

* Seeking routine (age-related) cataract extraction with monofocal intraocular lens implantation;
* Able to provide informed consent;
* Willing and able to attend all study visits and comply with treatment;
* Have dry eyes per dry eye questionnaire.

Exclusion Criteria

* Subjects who use of ocular drugs, other than the test article (for treatment group only) and other standard of care postoperative medications, during the study;
* History of intraocular or corneal surgery in the study eye;
* Use of artificial tears, steroids, or other medications as specified in the protocol;
* Clinically significant corneal scarring;
* Corneal degeneration, retinal degeneration or other ocular pathology as specified in the protocol.
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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Sr. Clinical Trial Lead, CDMA Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Principal Investigator

Valladolid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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DER646-P001

Identifier Type: -

Identifier Source: org_study_id

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