Systane Hydration in Subjects Undergoing Cataract Surgery

Cataract Clinical Trial

Official title:

Systane Hydration in Subjects Undergoing Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05056233
• Other study ID #: DER646-P001
• Status: Completed
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: January 12, 2023

Study information

• Verified date: February 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Other:
• Systane Hydration lubricant eye drops
Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye

Locations

Country	Name	City	State
Spain	Principal Investigator	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Day 30 post-operative
Secondary	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).	Up to Day 30 post-operative
Secondary	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."	Up to Day 30 post-operative
Secondary	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."	Up to Day 30 post-operative
Secondary	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."	Up to Day 30 post-operative