Systane Hydration in Subjects Undergoing Cataract Surgery

  • STATUS
    Recruiting
  • days left to enroll
    33
  • participants needed
    80
  • sponsor
    Alcon Research
Updated on 4 October 2022
intraocular lens implantation

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.

Details
Condition Dry Eye Disease, Cataract
Treatment Systane Hydration lubricant eye drops
Clinical Study IdentifierNCT05056233
SponsorAlcon Research
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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