Ganyan-1 in Dry Eye

Not Applicable

Not yet recruiting

• Conditions: Dry Eye; TCM
• Interventions: Drug: Sodium Hyaluronate; Drug: Ganyan1; Drug: Placebo; Drug: 1/2Ganyan1; Drug: 1/2Placebo

• Registration Number: NCT06818487
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

Ganyan -1 for the patients with dry eye

Detailed Description

Objective: Ganyan-1 for the patients with dry eye Methods: The investigators enrolled 232 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, week2, week4, week8, week12, and week16.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Study Start: 2025-03-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 232

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Sodium Hyaluronate	-
Placebo	Placebo	-
1/2Placebo	Sodium Hyaluronate	-
Ganyan1	Ganyan1	-
Ganyan1	Sodium Hyaluronate	-
1/2Ganyan1	Sodium Hyaluronate	-
1/2Ganyan1	1/2Ganyan1	-
1/2Placebo	1/2Placebo	-

Primary Outcome Measures

Name	Time	Method
OSDI	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 Outcome Measures

Name	Time	Method
SF-36	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.
TBUT	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.
SDS	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.
OQAS II	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.
Schirmer	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.
SAS	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.