Systane Hydration in Subjects Undergoing Cataract Surgery

Sponsor
Alcon Research (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05056233
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
3.4
Anticipated Duration (Months)
23.6
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 DiseaseIntervention/TreatmentPhase
  • 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 :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

ArmIntervention/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

    1. 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

    1. 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).

    2. 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."

    3. 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."

    4. 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:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Principal InvestigatorValladolidSpain47012

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT05056233
    Other Study ID Numbers:
    • DER646-P001
    First Posted:
    Sep 24, 2021
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 7, 2022