Systane Hydration in Subjects Undergoing Cataract Surgery

Alcon Research35 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Disease Cataract

Interventions

Systane Hydration lubricant eye dropsOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Principal Investigator

Valladolid, Spain

Outcomes

Primary Outcomes

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.