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A multicenter randomized controlled study on the treatment of acute bacterial conjunctivitis with Isatidis Radix Eye Drops

A multicenter randomized controlled study on the treatment of acute bacterial conjunctivitis with Isatidis Radix Eye Drops

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125592
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute bacterial conjunctivitis

Interventions

Joint group:Compound Isatidis Root Eye Drops combined with Levofloxacin Eye Drops
Control group:Levofloxacin Eye Drops
Experimental group:Isatis Root Eye Drops

Sponsors

Institute of Ophthalmology, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 to 65 years old; 2. Corrected visual acuity of both eyes >= 0.1; 3. Unilateral or bilateral onset; 4. Time from onset to hospital visit <= 72 hours, and the eyes have not received other antibacterial drugs or glucocorticoid treatment. If other antibacterial drugs or glucocorticoids were used within 72 hours, a 1-day washout period is required before enrollment; 5. Able to adhere to follow-up visits to the hospital; 6. The subject (or a legally authorized representative) understands and signs the approved informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those with other ocular surface diseases; such as those with ulcerative keratitis or corneal epithelial defects larger than punctate keratitis, iritis, or active inflammation and/or structural abnormalities in the anterior chamber, chronic dacryocystitis, etc; 2. Those with conjunctivitis caused by immune disorders, physical irritation, thyroid diseases, chickenpox or other systemic diseases; 3. Those suspected of having fungal, viral infections (such as herpes simplex virus) or Acanthamoeba keratitis based on clinical observation; 4. Glaucoma patients; 5. Those with a history of ocular surgery or ocular trauma within 3 months prior to enrollment; 6. Those who need to wear contact lenses during the trial; 7. Those with other acute or chronic infectious diseases; 8. Pregnant or lactating women, or those with recent plans for pregnancy; 9. Those with severe primary cardiovascular diseases, liver diseases, kidney diseases, blood system diseases, lung diseases, endocrine system diseases, or serious diseases that affect their survival, such as tumors; 10. Those with mental disorders; 11. Those who have used systemic glucocorticoids within 14 days before enrollment, or have used local ocular glucocorticoids or non-steroidal anti-inflammatory drugs within 1 week before enrollment, or are currently using immunosuppressants 12. Those who have participated in other clinical trials within 30 days before enrollment; 13. Those with a history of allergy to levofloxacin or the components of traditional Chinese medicine Banlangen; 14. Those whom the investigator deems unsuitable for the study for other reasons.

Design outcomes

Primary

MeasureTime frame
Palpebral conjunctiva congestion score;Scleral congestion score;Conjunctival secretion score;

Secondary

MeasureTime frame
Subjective questionnaire form;Chinese Medicine Syndrome Rating Scale Score;Breakup time of tear film;Ocular Surface Disease Index score;

Countries

China

Contacts

Public ContactWu Ningling

Institute of Ophthalmology, China Academy of Chinese Medical Sciences

Wuningling@126.com+86 10 6868 8877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026