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Completed

NCT Number: NCT05056233

Systane Hydration in Subjects Undergoing Cataract Surgery

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.

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Key information

Conditions

Dry Eye Disease Cataract Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Principal Investigator

Valladolid, 47012, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systane Hydration lubricant eye drops

Other

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

Other names: Systane Hydration® Ophthalmic Solution

Primary outcomes

  1. Corneal staining

    Time frame: 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 outcomes

  1. DEQ-5 Score

    Time frame: 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).

  2. Ocular Comfort Questionnaire Score: My eyes are comfortable

    Time frame: 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."

  3. Ocular Comfort Questionnaire Score: At the end of the day, my eyes feel comfortable

    Time frame: 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."

  4. Ocular Comfort Questionnaire Score: My eyes are comfortable all day long

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 24, 2021
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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