Systane Hydration in Subjects Undergoing Cataract Surgery

Sponsor

Alcon Research (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05056233

Collaborator

(none)

Enrollment

Location

Arms

10.4

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease Cataract	Other: Systane Hydration lubricant eye drops	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Systane Hydration in Subjects Undergoing Cataract Surgery

Actual Study Start Date :

Jan 18, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: Systane Hydration lubricant eye drops Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye Other Names: Systane Hydration® Ophthalmic Solution
No Intervention: No Treatment Investigator defined post-operative standard of care

Arm

Intervention/Treatment

Experimental: 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

Other: Systane Hydration lubricant eye drops

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

Other Names:

Systane Hydration® Ophthalmic Solution

No Intervention: No Treatment

Investigator defined post-operative standard of care

Outcome Measures

Primary Outcome Measures

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

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."

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.