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A Multicenter Clinical Study on the Efficacy and Safety of 0.05% Cyclosporine Eye Drops II in Patients with Periocular Dry Eye During the Perioperative Period

A Multicenter Clinical Study on the Efficacy and Safety of 0.05% Cyclosporine Eye Drops II in Patients with Periocular Dry Eye During the Perioperative Period

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117578
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-01-26
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative dry eye, including cataract, retinal diseases, and refractive surgery.

Interventions

Control group:Conventional treatment
Experimental group:Conventional treatment 0.05% Cyclosporine Eye Drops II

Sponsors

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. >=18 years of age; 2. patients meet the indications for eye-related surgery. 3. Voluntarily participate in this study and sign the informed consent form, and can cooperate to complete the examination and 3-month treatment and follow-up. If the subject is unable to read and sign the informed consent form due to incapacitation or other reasons, his/her guardian should act on behalf of the informed process and sign the informed consent form. 4. 1 week after surgery, the diagnostic criteria for dry eye in the ‘Chinese Expert Consensus on the Clinical Diagnosis and Treatment of Dry Eye (2024)’ were met: FBUT = 5 s or Schirmer ? <= 5 mm/5 min without surface anaesthesia, and one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and fluctuation of visual acuity in the eye, could be diagnosed as dry eye. Dry eye was diagnosed with 5 s< FBUT<=10 s or 5 mm/5 min under no surface anaesthesia< Schirmer ?<=10 mm/5 min, with one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and fluctuation of vision in the eye, as well as positive fluorescein staining of the cornea and conjunctiva. 5. Inclusion of surgical methods: cataract patients with cataract ultrasonic emulsification surgery; refractive patients with FS-LASIK (half femtosecond) surgery or SMILE full femtosecond surgery; patients with fundus disease with vitrectomy surgery or vitreous injection surgery.

Exclusion criteria

Exclusion criteria: 1.Patients who have undergone eye surgery or experienced eye trauma within six months prior to the baseline examination; 2.Patients with a history of intraocular inflammation within six months prior to the baseline examination; 3.Patients with other microbial infections of the eyeball and its appendages; 4.Patients with eyelid abnormalities (such as entropion, ectropion, tumors, edema, eyelid spasms, incomplete eyelid closure, trichiasis, ptosis, eyelid laxity, etc.); 5.Patients who are simultaneously participating in clinical trials of other ophthalmic drugs or medical devices. 6.Patients with severe primary diseases affecting the liver, kidneys, and hematopoietic system, as well as those with mental disorders; 7.Use of hormones, nonsteroidal anti-inflammatory drugs, immunosuppressants, cholinergic drugs, or other medications that may affect the study due to other diseases within 3 months prior to surgery. 8.Allergic to 0.05% cyclosporine eye drops; 9.Pregnant or breastfeeding women;

Design outcomes

Primary

MeasureTime frame
Tear Film Breakup Time (BUT);

Secondary

MeasureTime frame
Ocular Surface Disease Index (OSDI) Score;

Countries

China

Contacts

Public ContactHu liu

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

liuhu66@163.com+86 25 6830 3165

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026