Patients with non-infectious anterior uveitis
Conditions
Interventions
1% prednisolone acetate eye drops group:1% prednisolone acetate eye drops
1.0% VVN461 eye drops group:1.0% VVN461 eye drops
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. When signing the Informed Consent Form (ICF), the subject must be between 18 and 70 years old (inclusive); 2. During screening, the affected eye must be diagnosed with non-infectious anterior uveitis (acute or recurrent acute, only patients with unilateral onset are eligible); 3. During screening, the affected eye must have an anterior chamber cell grade of 2 or 3 [SUN criteria]; 4. During screening, the affected eye must have an anterior chamber flare score >= 1 [SUN criteria]; 5. The best corrected visual acuity of the affected eye must be >= 0.1 (decimal notation); 6. The subject understands the purpose of the trial, the nature of the investigational drug, the possible risks, and their own rights, voluntarily agrees to participate in the clinical trial, and signs the informed consent; 7. The subject is willing and able to comply with the study protocol and complete the scheduled visits during the study period.
Exclusion criteria
Exclusion criteria: Eye Section 1. During screening, the affected eye has an anterior chamber cell grade of 4 or there is purulent accumulation in the anterior chamber; 2. During screening, the contralateral eye has active anterior chamber inflammation (if the contralateral eye has a history of anterior uveitis but shows no active anterior chamber inflammation at this screening, enrollment is allowed); 3. During screening, the affected eye has contraindications to mydriatic treatment; 4. Prior to screening, the affected eye has received ocular corticosteroid injections, including: (1) Periocular injections of short-acting corticosteroids (e.g., methylprednisolone) 25 mmHg or a history of glaucoma; 14. During screening, if either eye has a history of steroid-dependent ocular hypertension; 15. If the study eye has undergone any intraocular surgery within 3 months before screening and/or ocular laser treatment within 1 month before screening; 16. During screening, if the study eye has patchy corneal epithelial defects, corneal erosion, or ulcers; 17. During screening, if either eye has evidence of or is suspected to have an active ocular infection (viral, bacterial, fungal, etc.); 18. If the study eye requires wearing contact lenses or scleral lenses during the study period; Whole Body 19. During screening, have uncontrolled systemic diseases that may affect the results of the clinical trial (such as malignant tumors, diabetes, myasthenia gravis, active hepatitis, renal failure, or severe neurological, cardiovascular, digestive, urinary, endocrine, respiratory, or other systemic diseases); 20. Have used systemic immunosuppressants or glucocorticoids within 30 days before screening or during the clinical trial, and require or are expected to require dose adjustments (those who have had stable doses within 30 days before screening and are expected to remain stable during the study may be enrolled); 21. Have participated in other drug or device clinical trials or used trial drugs or devices within 30 days before sc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in anterior chamber cell score from baseline to the 14-day visit;Changes in anterior chamber cell score from baseline to the 14-day visit; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with an anterior chamber flare score of 0 at the 28-day visit in the study;The proportion of subjects with an anterior chamber cell score of 0 at the Day 28 visit in the study;The proportion of subjects whose anterior chamber cell score in the study eye decreased by >=2 grades from baseline at the Day 28 visit;The proportion of subjects whose anterior chamber cell score in the study eye decreased by >=2 grades from baseline at the Day 14 visit;Study the change in anterior chamber flare score compared to baseline;The proportion of subjects who experienced treatment failure during the study treatment period (requiring salvage therapy);The time when the anterior chamber cell score of the study eye first recovers to 0 after treatment;The proportion of subjects with an anterior chamber flare score of 0 at the Day 14 visit in the study eye;Change in anterior chamber cell score compared to baseline at the Day 28 visit; | — |
Countries
China
Contacts
Public ContactPeizeng Yang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed