A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease
Overview
- Phase
- Phase 3
- Intervention
- CsA Ophthalmic Gel
- Conditions
- Dry Eye
- Sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Enrollment
- 644
- Locations
- 1
- Primary Endpoint
- Proportion of patients whose corneal fluorescein staining score (ICSS) decreased by ≥1 point from baseline at visit 5 (study eye)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe dry eye disease .
Detailed Description
A multicenter,randomized, double-blind, vehicle-controlled Study.Subjects will be randomly assigned to the experimental group and the control group,experimental group: CsA eye gel: 0.3 g: 0.15 mg, once daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a day Control group: vehicle. One drop into the eye, once daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a day
Investigators
Eligibility Criteria
Inclusion Criteria
- •1）18≤Age≤80, both male and female 2）According to the symptoms and signs and ophthalmologic examinations, the patients were diagnosed as moderate to severe dry eye
- •EDS score is more than 40 points;
- •BUT is less than 10 s;
- •Schirmer test result is less than 10mm/5 min;
- •ICSS≥2 points. 3）The ICSS score of baseline decreased by≤ 20% compared with that of screening period 4）Agree to participate in the study and voluntarily sign informed consent.
Exclusion Criteria
- •Severe dry eye patients requiring surgical treatment
- •Had inner eye surgery within 12 months prior to screening or required inner eye surgery during the study period;Eyelid surgery was performed within 6 months prior to screening
- •Patients receiving permanent lacrimal insertion or patients receiving temporary lacrimal insertion within 6 months prior to screening;
- •Operation-induced dry eye
- •Glaucoma patients;
- •Unwilling to avoid wearing contact lenses;
- •Systemic inflammation or active eye infection and blepharitis;
- •Patients with multiple episodes of viral keratitis
- •Patients with ocular cicatricial pemphigoid, obvious conjunctival scar, ocular chemical burn and neurotrophic keratoconjunctivitis
- •Patients with malignant tumors in the past 5 years, except the thoroughly cured basal cell carcinoma of skin, squamous cell carcinoma in situ of skin, and primordial cervical cancer;
Arms & Interventions
Experimental Group
322 subjects will be treated with CsA eye gel: 0.3 g: 0.15 mg, 1 times daily, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Intervention: CsA Ophthalmic Gel
Experimental Group
322 subjects will be treated with CsA eye gel: 0.3 g: 0.15 mg, 1 times daily, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Intervention: Hypromellose Eye Drop
Control group
322 subjects will be treated with Placebo : 0 g: 0mg, 1 times daily, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Intervention: Placebo
Control group
322 subjects will be treated with Placebo : 0 g: 0mg, 1 times daily, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Intervention: Hypromellose Eye Drop
Outcomes
Primary Outcomes
Proportion of patients whose corneal fluorescein staining score (ICSS) decreased by ≥1 point from baseline at visit 5 (study eye)
Time Frame: 84 days after admission
ICSS：no staining = 0，few/rare punctate lesions = 1，discrete and countable lesions = 2，lesions too numerous to count，but not coalescent = 3，coalescent = 4
Secondary Outcomes
- corneal fluorescein staining score (ICSS)at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular)(14 days after admission ，42 days after admission ，84days days after admission)
- oxford score at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular)(14 days after admission ，42 days after admission ，84days days after admission)
- EDS score at the NO.3, NO.4 and NO.5 visit was compared with the baseline EDS score (binocular)(14 days after admission ，42 days after admission ，84days days after admission)
- Average changes in VAS scores of 6 dry eye symptoms (burning/needling sensation, pruritus, foreign body sensation, discomfort, photophobia and pain) at the NO.3, NO.4 and NO.5 visit were compared with baseline (binocular)(14 days after admission ，42 days after admission ，84days days after admission)
- Tear break-up time(BUT) at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular)(14 days after admission，42 days after admission ，84days days after admission)
- Schirmer's II test (with anesthetic) at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular)(14 days after admission ，42 days after admission ，84days days after admission)