Clinical TrialID 8185

The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye

NCT06043908

Dry Eye

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Record Fields

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Clinical Trial Id
8185
Evidence Id
8185
Core Evidence Id
8185
Source Clinical Trial Id
8183
Herb2 Clinical Trial Id
HBCT008183
Nct Id
NCT06043908
Title
The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye
Status
Recruiting
Phase
Phase 4
Study Result
No
Study Condition
Dry Eye
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Intervention
DRUG: artificial tear eyedrops|DRUG: 0.05% cyclosporine eyedrops
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Intervention Purpose
Treatment
Gender
All
Age
Adult
Enrollment
60
Outcome Measure
ocular surface disease index (OSDI), OSDI is one of the most frequently used questionnaires for evaluation of dry eye disease (DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100., from baseline to 3 months after treatment|Tear break-up time (TBUT)(s), BUT is the time from normal blinking to the first appearance of a break in the tear film., from baseline to 3 months after treatment|Corneal fluorescein staining (CFS), The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior). The scores range from 0 to 15., from baseline to 3 months after treatment|Schirmer I test (SIt) (mm/5 minutes), The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters., from baseline to 3 months after treatment|Lissamine green staining, To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded., from baseline to 3 months after treatment
Sponsor Collaborator
Peking University Third Hospital
Funded By
OTHER
Location
Hong Qi, Beijing, Beijing, 100191, China
Other Id
RS01
Start Date
2022-08-31
Primary Completion Date
2023-12-31
Completion Date
2023-12-31
First Posted
2023-09-21
Results First Posted
Last Update Posted
2023-09-21
Study Document
Study Url
https://clinicaltrials.gov/study/NCT06043908
Title Cn
Title En
The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye
Bilingual Status
semi_complete