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Systane Hydration in Subjects Undergoing Cataract Surgery

Primary Purpose

Dry Eye Disease, Cataract

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Systane Hydration lubricant eye drops
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

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

Key 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.
  • Other protocol-defined inclusion criteria may apply.

Key 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.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

  • Principal Investigator

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Systane Hydration

No Treatment

Arm Description

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

Investigator defined post-operative standard of care

Outcomes

Primary Outcome Measures

Corneal staining
The National Eye Institute (NEI) grading scale will be used to evaluate the five corneal regions: Superior, inferior, central, temporal and nasal. Each region will be graded on a 0-3 scale, where 0 = normal (no staining), 1 = mild/superficial stippling micropunctate staining, 2 = moderate/macropunctate staining with some coalescent areas, and 3 = severe/numerous coalescent macropunctate areas and/or patches. The regions will be summed for a resultant overall score of 0 to 15.

Secondary Outcome Measures

DEQ-5 Score
The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to 5 questions using a 0-4 Likert-type scale, for a resultant overall score of 0 (best) to 20 (worst).
Ocular Comfort Questionnaire Score: My eyes are comfortable
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "My eyes are comfortable."
Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "At the end of the day, my eyes feel comfortable."
Ocular Comfort Questionnaire Score: My eyes are comfortable all day long
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "My eyes are comfortable all day long."

Full Information

First Posted
September 15, 2021
Last Updated
February 21, 2023
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05056233
Brief Title
Systane Hydration in Subjects Undergoing Cataract Surgery
Official Title
Systane Hydration in Subjects Undergoing Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
January 12, 2023 (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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systane Hydration
Arm Type
Experimental
Arm Description
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
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
Investigator defined post-operative standard of care
Intervention Type
Other
Intervention Name(s)
Systane Hydration lubricant eye drops
Other Intervention Name(s)
Systane Hydration® Ophthalmic Solution
Intervention Description
Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye
Primary Outcome Measure Information:
Title
Corneal staining
Description
The National Eye Institute (NEI) grading scale will be used to evaluate the five corneal regions: Superior, inferior, central, temporal and nasal. Each region will be graded on a 0-3 scale, where 0 = normal (no staining), 1 = mild/superficial stippling micropunctate staining, 2 = moderate/macropunctate staining with some coalescent areas, and 3 = severe/numerous coalescent macropunctate areas and/or patches. The regions will be summed for a resultant overall score of 0 to 15.
Time Frame
Up to Day 30 post-operative
Secondary Outcome Measure Information:
Title
DEQ-5 Score
Description
The Dry Eye Questionnaire-5 (DEQ-5) is a patient-reported outcome measures questionnaire designed to assess symptoms of dry eye disease. Subjects will respond to 5 questions using a 0-4 Likert-type scale, for a resultant overall score of 0 (best) to 20 (worst).
Time Frame
Up to Day 30 post-operative
Title
Ocular Comfort Questionnaire Score: My eyes are comfortable
Description
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "My eyes are comfortable."
Time Frame
Up to Day 30 post-operative
Title
Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable
Description
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "At the end of the day, my eyes feel comfortable."
Time Frame
Up to Day 30 post-operative
Title
Ocular Comfort Questionnaire Score: My eyes are comfortable all day long
Description
Subjects will provide a comfort score (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) to the following question: "My eyes are comfortable all day long."
Time Frame
Up to Day 30 post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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. Other protocol-defined inclusion criteria may apply. Key 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. Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, CDMA Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Principal Investigator
City
Valladolid
ZIP/Postal Code
47012
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Systane Hydration in Subjects Undergoing Cataract Surgery

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