Clinical Trial Radar

Change from Baseline in Noninvasive Tear Breakup Time (NIBUT)

The interval between a complete blink and the first breakup of tear film (indicated by a break or deformed Placido disc image on the screen) will be recorded. The measurements are carried out 3 times and the average value is considered as NIBUT.

Baseline, Week 4, Week 8, Week 16, Week 28

Change From Baseline in Tear Meniscus Height (TMH)

The digital slit lamp (SL990N, CSO, Italy) is applied to take images of the tear meniscus at the lower lid margin in a dark room. The tear meniscus height directly below the central pupil is measured with the system's built-in caliper tool.

Baseline, Week 4, Week 8, Week 16, Week 28

Change From Baseline in Ocular Surface Disease Index (OSDI)

The OSDI scale is used to assess subjective symptoms related to dry eye, including ocular symptoms, visual function and environmental triggers, with a total score ranging from 0 to 100. The higher the score, the more severe the subjective symptoms.

Baseline, Week 4, Week 8, Week 16, Week 28

Change From Baseline in Corneal Fluorescein Staining (CFS)

Sodium fluorescein ophthalmic strips (Tianjin Jingming New Technology Development Co., Ltd., China) are used to evaluate corneal epithelial damage. According to the Oxford grading scheme, the CFS score ranges from 0 (no damage) to 5 (severe damage).

Baseline, Week 4, Week 8, Week 16, Week 28

Change From Baseline in Corneal Topography

The corneal topography system is used to take photographs. The subjects are asked to blink naturally 3 to 4 times, and after the last full blink, they look at the central light source of the Placido disk for 10 s. The researchers take photographs of the anterior corneal surface immediately after the blink and at 10 s of continuous gaze. The SRI and SAI are systematically analyzed and obtained at 10 s.

Baseline, Week 4, Week 8, Week 16, Week 28

Change From Baseline in Corneal and Conjunctival sensation

The Cochet-Bonnet perception meter (Luneau Chartres, France) will be used to evaluate the corneal perception (including central, superior, inferior, nasal, and temporal corneas, all 2 mm from the corneal rim) and conjunctival perception (including temporal and nasal bulbar conjunctivae, both 3 mm from the corneal rim; superior and inferior conjunctiva, at the center of the eyelid). The measured fiber length will be converted to g/mm2 according to the criteria provided by the supplier, with a higher threshold indicating a more insensitive perception.

Baseline, Week 4, Week 8, Week 16, Week 28

Change From Baseline in Schirmer I test (SⅠT)

SⅠT will be performed using a tear detection filter strip (Tianjin Jingming New Technology Development Co., Ltd., China). Patients are requested to avoid eye movement. The strips will be removed after 5 min, and recorded the wetting length.

Baseline, Week 4, Week 8, Week 16, Week 28

Change From Baseline in Numerical Rating Scale (NRS)

Subjects are asked to rate their current Iocular pain intensity in the right and left eye (0-10 numerical rating scale, NRS) followed by placement of 0.4% hydroxybuprocaine hydrochloride (Santen Pharmaceutical Co., LTD., Japan), and rerating of pain 30 seconds later.

Baseline, Week 4, Week 8, Week 16, Week 28

Change From Baseline in Chinese Dry Eye Related Quality of Life Scale (CDERQOL)

CDERQOL includes 5 domians containing 45 items rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree).

Baseline, Week 4, Week 8, Week 16, Week 28

Adverse events

Any adverse events will be recorded. EA-related adverse events include local bleeding, subcutaneous hematoma, pain, itch, infection, and generalized symptoms such as dizziness and palpitation during treatment.

Week 4