Ganyan-1 in Dry Eye

NCT06818487 | Not Yet Recruiting

• 1 other identifier: DED_TCM_2024
• Study Type: interventional
• Target: 219
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ganyan -1 for the patients with dry eye

Conditions

Dry Eye; TCM

Keywords

Dry eye; TCM; RCT

Outcome Measures

Primary Outcomes (1)

• OSDI

  The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/ areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eve (33-100).

  Baseline, week 2, 4, 8, 12 and 16

Secondary Outcomes (6)

• TBUT

  Baseline, week 2, 4, 8, 12 and 16

• Schirmer

  Baseline, week 2, 4, 8, 12 and 16

• SF-36

  Baseline, week 2, 4, 8, 12 and 16

• SAS

  Baseline, week 2, 4, 8, 12 and 16

• SDS

  Baseline, week 2, 4, 8, 12 and 16

Study Arms (3)

Ganyan1

EXPERIMENTAL

Drug: Ganyan1; Drug: Sodium Hyaluronate

1/2Ganyan1

EXPERIMENTAL

Drug: Sodium Hyaluronate; Drug: 1/2Ganyan1

Placebo

PLACEBO COMPARATOR

Drug: Sodium Hyaluronate; Drug: Placebo

Interventions

Ganyan1 DRUG

During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.

Ganyan1

Sodium Hyaluronate DRUG

Participants received 0.1% sodium hyaluronate eye drop

1/2Ganyan1; Ganyan1; Placebo

1/2Ganyan1 DRUG

During the treatment period, participants will receive the following Chinese herbal granules, including Chrysanthemum, Dendrobium, Salvia miltiorrhiza, Gypsum Fibrosum, and Goji berries, administered twice daily at a dose of 5 g per time for a duration of 4 weeks.

1/2Ganyan1

Placebo DRUG

Participants will receive the following placebo Chinese herbal granules, administered twice daily at a dose of 10 g per time for a duration of 4 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Dong Wu, Doctor

CONTACT

8613810988682; wudong0120@outlook.com

Haihong Lian, Doctor

CONTACT

8618811612190; lianhh123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 25, 2025

Record last verified: 2024-12