A Phase Ⅱ, Multicenter, Randomized, Single-blind, Positive-controlled, Dose-finding Study to Assess the Efficacy and Safety of CsA Ophthalmic Gel in Subjects With Moderate to Severe Aqueous-Deficient Dry Eye (ADDE)
Overview
- Phase
- Phase 2
- Intervention
- CsA eye gel
- Conditions
- Dry Eye
- Sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular)
- Status
- Completed
- Last Updated
- 5 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 tear deficiency dry eye with different dosage, frequency and concentration, and to preliminarily determine the optimal dosage, frequency and concentration, so as to provide a theoretical basis for the design of follow-up clinical studies.
Detailed Description
A multicenter, randomized, single-blind, positive controlled exploratory study will be conducted with cyclosporine A ophthalmic emulsion as the control drug. The experimental drugs were divided into three groups: Treatment group A: CsA eye gel: 0.3 g: 0.15 mg, once daily； Treatment group B: CsA eye gel: 0.3 g: 0.15 mg, twice daily, interval of about 12 hours； Treatment group C: CsA eye gel: 0.3 g: 0.3 mg, once daily. One drop into each eye when you use it. Control group: CsA emulsion: 0.4 ml: 0.2 mg. One drop into the eye, 2 times daily with an interval for 12 hours.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18, both male and female;
- •Pregnancy tests were negative for women of childbearing age and contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) were taken during the trial. Men are willing to use approved contraceptive methods (possibly using condoms and spermicides or oral contraceptives, implants or injections of contraceptives, intrauterine devices, diaphragms and spermicides) or sexual partner infertility;
- •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;
- •In any area, corneal fluorescein staining was more than 2 points.
- •The anatomy of the eyelids is normal and has normal blinking function;
- •Patients with newly diagnosed dry eye disease, or who are undergoing dry eye treatment, voluntarily discontinue treatment within 72 hours of entering the screening period;
- •Ability and willingness to participate in all research assessments and all planned visits during the pilot period in accordance with the programme requirements;
Exclusion Criteria
- •Allergy to CsA, fluorescein or any component of the drug is known;
- •Severe dry eye patients requiring surgical treatment;
- •Glaucoma patients;
- •Unwilling to avoid wearing contact lenses;
- •Within 12 months prior to the start of the study, intraocular surgery or internal surgery was necessary;
- •Eyelid surgery was performed within 6 months prior to the start of the study, or dry eye secondary to surgery;
- •Those who had undergone corneal refractive surgery or keratoplasty;
- •Congenital lacrimal gland or meibomian gland deficiency or lacrimal gland obstructive diseases;
- •Systemic inflammation or active eye infection and blepharitis;
- •Patients with ocular cicatricial pemphigoid, obvious conjunctival scar, ocular chemical burn and neurotrophic keratoconjunctivitis;
Arms & Interventions
0.3 g: 0.15 mg（1)&Hypromellose Eye Drops
Sixty 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 eye gel
0.3 g: 0.15 mg（1)&Hypromellose Eye Drops
Sixty 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 Drops
0.3 g: 0.15mg（2)&Hypromellose Eye Drops
Sixty subjects will be treated with CsA eye gel: 0.3 g: 0.15 mg, 2 times daily, interval of about 12 hours, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Intervention: CsA eye gel
0.3 g: 0.15mg（2)&Hypromellose Eye Drops
Sixty subjects will be treated with CsA eye gel: 0.3 g: 0.15 mg, 2 times daily, interval of about 12 hours, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Intervention: Hypromellose Eye Drops
0.3 g: 0.3 mg &Hypromellose Eye Drops
Sixty subjects will be treated with CsA eye gel: 0.3 g: 0.3 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 eye gel
0.3 g: 0.3 mg &Hypromellose Eye Drops
Sixty subjects will be treated with CsA eye gel: 0.3 g: 0.3 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 Drops
0.4 ml: 0.2 mg &Hypromellose Eye Drops
Sixty subjects will be treated with CsA for eye emulsion: 0.4 ml: 0.2 mg, 2 times daily, interval of about 12 hours, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Intervention: CsA for eye emulsion
0.4 ml: 0.2 mg &Hypromellose Eye Drops
Sixty subjects will be treated with CsA for eye emulsion: 0.4 ml: 0.2 mg, 2 times daily, interval of about 12 hours, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Intervention: Hypromellose Eye Drops
Outcomes
Primary Outcomes
The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular)
Time Frame: 84 days after admission
0-100 points VAS score was evaluated
Secondary Outcomes
- Comparison of the NO.3, NO.4, NO.5 visit and baseline Schirmer changes(14 days after admission ，42 days after admission ，84 days after admission)
- The EDS score at the NO.3, NO.4 visit were compared with the baseline EDS score (binocular)(14 days after admission ，42days 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)
- Comparison of the NO.3, NO.4, NO.5 visit and baseline corneal fluorescein staining changes(14 days after admission ，42 days after admission ，84 days after admission)
- Comparison of the NO.3, NO.4, NO.5 visit and baseline BUT changes(14 days after admission ，42 days after admission ，84 days after admission)