Systane Hydration in Subjects Undergoing Cataract Surgery

Alcon

Status: Completed

Conditions: Cataract; Dry Eye Disease

Treatments: Other: Systane Hydration lubricant eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT05056233

DER646-P001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Systane Hydration

Experimental group

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

Treatment:

Other: Systane Hydration lubricant eye drops

No Treatment

No Intervention group

Description:

Investigator defined post-operative standard of care