Systane Hydration in Subjects Undergoing Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract; Dry Eye Disease
• Interventions: Other: Systane Hydration lubricant eye drops

• Registration Number: NCT05056233
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-24
• Study Start: 2022-01-18
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systane Hydration	Systane Hydration lubricant eye drops	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

Primary Outcome Measures

Name	Time	Method
Corneal staining	Up to Day 30 post-operative	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

Name	Time	Method
DEQ-5 Score	Up to Day 30 post-operative	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	Up to Day 30 post-operative	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	Up to Day 30 post-operative	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	Up to Day 30 post-operative	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."

Trial Locations

Locations (1)

Principal Investigator; 🇪🇸 Valladolid, Spain