An interventional study of Systane Hydration lubricant eye drops in Dry Eye Disease and Cataract, sponsored by Alcon Research. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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
Investigator defined post-operative standard of care
Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye
Also known as: Systane Hydration® Ophthalmic Solution
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.
Time frame: Up to Day 30 post-operative
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).
Time frame: Up to Day 30 post-operative
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."
Time frame: Up to Day 30 post-operative
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."
Time frame: Up to Day 30 post-operative
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."
Time frame: Up to Day 30 post-operative
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Jan 2023, 11 months.
Of 108 industry-sponsored interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's 11 months is above that.
Counting every sponsor, half of 293 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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