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NCT Number: NCT06818487

Ganyan-1 in Dry Eye

Ganyan -1 for the patients with dry eye

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Sodium Hyaluronate

Drug

Participants received 0.1% sodium hyaluronate eye drop

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.

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.

Primary outcomes

  1. OSDI

    Time frame: Baseline, week 2, 4, 8, 12 and 16

    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).

Secondary outcomes

  1. TBUT

    Time frame: Baseline, week 2, 4, 8, 12 and 16

    Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps' photos over time. A TBUT under 10 seconds is considered abnormal.

  2. Schirmer

    Time frame: Baseline, week 2, 4, 8, 12 and 16

    The Schirmer test is objectively used to measure tear secretion without anesthetized. A healthy eye should wet more than 10 mm of the standard filter strip in 5 minutes. The travel rate along the test strip is proportional to the tear production rate.

  3. SF-36

    Time frame: Baseline, week 2, 4, 8, 12 and 16

    36-Item Short Form Health Survey (SF36) measures quality of life on the basis of eight dimensions or concepts that are frequently used in health studies. These eight dimensions are estimated from eight subscales that examine physical functioning (SF36-PF), role functioning-physical (SF36-RP), bodily pain (SF36-BP), general health (SF36- GH), vitality (SF36-VT), social functioning (SF36-SF), role functioning-emotional (SF36-RE), mental health (SF36-MH) and reported health transition (SF36-HT). Item responses were ranaina from 0 (best) to 100 (worst), with hiaher scores are equivalent to areater severity of better quality of life.

  4. SAS

    Time frame: Baseline, week 2, 4, 8, 12 and 16

    The SAS is a 20-item self-report instrument designed to assess anxiety symptoms in clinical and research settings. This scale ranges from 20 to 80, with lower scores indicating better self-reported mental health and fewer anxiety symptoms.

  5. SDS

    Time frame: Baseline, week 2, 4, 8, 12 and 16

    Medical Outcomes from study 20-Item Self-Rating Depression Scale. This scale range is 0-100 with lower scores indicating better self-reported mental health.

  6. OQAS II

    Time frame: Baseline, week 2, 4, 8, 12 and 16

    Medical Outcomes from the OQAS II Visual Quality Assessment The OQAS II measures visual quality using several optical parameters. Scores are generated based on metrics like the Modulation Transfer Function (MTF) and Objective Scatter Index (OSI). The scale ranges from 0-100, with lower scores indicating better optical quality and fewer distortions. Change is calculated as the score at follow-up time points (e.g., post-treatment or surgery) minus the baseline score.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Wu, Doctor

CONTACT

[email protected]

8613810988682

Haihong Lian, Doctor

CONTACT

[email protected]

8618811612190

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Ganyan-1 in Dry Eye: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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