Ganyan-1 in Dry Eye

Capital Medical University

Status: Not yet enrolling

Conditions: TCM; Dry Eye

Treatments: Drug: Sodium Hyaluronate; Drug: 1/2Ganyan1; Drug: Placebo; Drug: Ganyan1

Study type: Interventional

Funder types: Other

Identifiers

NCT06818487

DED_TCM_2024

Details and patient eligibility

About

Ganyan -1 for the patients with dry eye

Full description

Objective: Ganyan-1 for the patients with dry eye Methods: The investigators enrolled 219 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, week2, week4, week8, week12, and week16.

Enrollment: 219 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age >=18 and Age <=70, complaint of DED symptoms for 6 months or longer at screening.

2. ocular surface disease index (OSDI) score of 25 or higher. 4. tear film breakup time (TFBUT) of 5 seconds or less. 5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes. 6. CFS score of 4 or higher.

Exclusion criteria

1. History systemic autoimmune diseases and ocular/periocular malignancy.
2. Clinically relevant slitlamp findings or abnormal lid anatomy.
3. Active ocular allergies and active infection.
4. Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

219 participants in 3 patient groups, including a placebo group

Ganyan1

Experimental group

Treatment:

Drug: Ganyan1

Drug: Sodium Hyaluronate

1/2Ganyan1

Experimental group

Treatment:

Drug: 1/2Ganyan1

Drug: Sodium Hyaluronate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Sodium Hyaluronate