Clinical trial NCT06043908: The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry Eye
Official title: The Effect of Topical 0.05% Cyclosporine Eye Drops on Post-refractive Surgery Dry Eye
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dry Eye
Keywords: dry eye, refractive surgery, 0.05% cyclosporine
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment.

Detailed description: The purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment. At the same time, this study further observed whether 0.05% cyclosporine eyedrops combined with artificial tear eyedrops were more beneficial to ocular surface repair and tear film homeostasis compared with traditional artificial tears alone.

Eligibility criteria: Inclusion Criteria:

* Patients who suffering from dry eye after refractive surgery with age between 18 and 45 years old.
* Any gender.
* Provision of written informed consent.

Exclusion Criteria:

* active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.
* Pregnant and lactating women, or those planning a pregnancy over the course of the study.
* Uncontrolled systemic disease.
* Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.

Primary outcomes:
measure: ocular surface disease index (OSDI)
timeFrame: from baseline to 3 months after treatment
measure: Tear break-up time (TBUT)(s)
timeFrame: from baseline to 3 months after treatment
measure: Corneal fluorescein staining (CFS)
timeFrame: from baseline to 3 months after treatment
measure: Schirmer I test (SIt) (mm/5 minutes)
timeFrame: from baseline to 3 months after treatment
measure: Lissamine green staining
timeFrame: from baseline to 3 months after treatment
Secondary outcomes:
measure: the concentration of Interleukin-1β (IL-1β) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of Interleukin-6 (IL-6) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of Interleukin-10 (IL-10) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of Interleukin-23 (IL-23) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of Interleukin-17A (IL-17A) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of tumor necrosis factor-α (TNF-α)(pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of interferon-γ (IFN-γ)(pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of granulocyte-macrophage colony-stimulating factor (GM-CSF)(pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of substance P (SP)(pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of alpha-melanocyte-stimulating hormone (α-MSH) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of β-endorphin (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of neurotensin (pg/ml
timeFrame: from baseline to 3 months after treatment
measure: the concentration of oxytocin(pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: corneal sensitivity (range, 60-0 mm)
timeFrame: from baseline to 3 months after treatment
measure: sub-basal corneal nerve density (mm/mm2)
timeFrame: from baseline to 3 months after treatment
measure: numerical rating scale (NRS)
timeFrame: from baseline to 3 months after treatment
measure: NPSI-Eye (range 0-100 score)
timeFrame: from baseline to 3 months after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hong Qi
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi
role: PRINCIPAL_INVESTIGATOR
References: