Effect of cyclosporine eye drops on dry eye after refractive surgery
The Effect of Topical 0.05% Cyclosporine Eye Drops on Post-refractive Surgery Dry Eye
This study is testing if using cyclosporine eye drops along with artificial tears can help people with dry eyes feel better after having refractive eye surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06043908 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of 0.05% cyclosporine eye drops combined with artificial tears in treating dry eye symptoms in patients who have undergone corneal refractive surgery. It will assess changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment. The study will compare the benefits of this combination therapy against traditional artificial tears alone to determine its impact on ocular surface repair and tear film stability.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 45 who experience dry eye symptoms following refractive surgery.
Not a fit: Patients with active ocular infections, severe eyelid inflammation, or systemic diseases affecting corneal nerves may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve dry eye symptoms and enhance recovery for patients after refractive surgery.
How similar studies have performed: Previous studies have shown promising results with cyclosporine in treating dry eye, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Hong Qi — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Hong Qi — Peking University Third Hospital
- Study coordinator: Hong Zhao
- Email: doctorqihong@163.com
- Phone: 13901066889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.