Scripps Poway Eyecare & Optometry
San Diego, California, 92131, United States
NCT Number: NCT06219577
Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
San Diego, California, 92131, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Exclusion criteria
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Eyedrop
Eyedrop
Time frame: Change from baseline to 2 weeks
The Symptom Assessment iN Dry Eye (SANDE) questionnaire.
Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root[Q1 * Q2].
Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.
Time frame: Change from baseline to 2 weeks
Baseline corneal and conjunctival staining with sodium fluorescein and Wratten filter assessed OU using the Academy of Ophthalmology 5 quadrant scheme. Each quadrant will be graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome.
Time frame: Change from baseline to 2 weeks
Scripps Poway Eyecare and Optometry
Other
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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