A Randomized Controlled Trial of 3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 94
- 主要终点
- Change in Cornea Fluorescein Staining (CFS) score from baseline to 4 weeks, 8 weeks and 16 weeks between study groups
研究概览
简要总结
The aim of the study is to investigate whether patients with moderate-to-severe VKC and keratitis will benefit from the addition of Diquafosol ophthalmic solution in terms of symptoms and signs of VKC, tear film metrics, ocular surface inflammation and quality of life. Potential beneficial effect of Diquafosol treatment on top of current standard use of topical immunosuppressant therapy in VKC would be studied.
Subject at least aged 6 and above with clinical diagnosis of vernal keratoconjunctivitis would be invited to join this study and perform the following assessments:
- best corrected visual acuity,
- slit lamp biomicroscope examination,
- tear meniscus height and non-invasive keratographic tear breakup time(NIKBUT) measurement,
- cornea fluorescein staining (CFS) and
- Schirmer's I test. Doctor will prescribe eyedrop, 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion or 0.1% Cyclosporin A cationic ophthalmic emulsion at the end of examination. Subjects will be followed up at 4 weeks, 8 weeks, 16 weeks after treatment.
All participants will be required to answer a standardised questionnaire relating to severity of VKC and dry eye disease.
详细描述
Aim To compare the four-month clinical efficacy of topical treatment with 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion versus 0.1% Cyclosporin A cationic ophthalmic emulsion in reducing symptoms and signs of active moderate-to-severe vernal keratoconjunctivitis (grade of 2 to 4 on the Bonini severity scale) with keratitis (corneal fluorescein staining score of 1-5 on the modified Oxford scale).
Study design A single-centre prospective double-blinded randomized controlled trial
Hypothesis The addition of topical treatment with 3% Diquafosol ophthalmic solution is superior to 0.1% Cyclosporin cationic ophthalmic emulsion alone in improving symptoms and signs of moderate-to-severe VKC with keratitis at four months of use.
Methods This is a single-centre, prospective, 16-week, randomized, double-blinded controlled clinical trial investigating the clinical efficacy and safety of combined topical treatment with 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion and versus topical treatment with 0.1% Cyclosporin A cationic ophthalmic emulsion in patients with moderate-to-severe vernal keratoconjunctivitis and keratitis. The study will also investigate the longitudinal changes in tear cytokines and correlate them with changes in VKC signs and tear film metrics. The study will be performed in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization, Good Clinical Practice guidelines, and all applicable laws and regulations. Written informed consent will be obtained from each patient before enrolment in the study. A clinical trials certificate will be obtained from the Department of Health, Hong Kong SAR.
Sample size The study will recruit 94 subjects with moderate-to-severe VKC at eye clinics in Hong Kong West cluster (QMH and GH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
It is a double-masked randomized study. Assigned treatment of a specific patients would be kept confidential in both the recruited participants and investigators. To keep the investigators and subjects blind to the study treatment, all investigational drugs are removed from their commercial packaging, wrapped in aluminium foil, double-wrapped in plastic bags, and distributed to participants by an independent clinical research coordinator.
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject at least aged 6 and above
- •Clinical diagnosis of vernal keratoconjunctivitis
- •Evidence of active moderate-to-severe disease: At least Grade 2 on the Bonini scale of VKC clinical presentation (moderate-to-severe) [38].
- •Evidence of keratitis: At least Grade 1 on the Modified Oxford scale for cornea fluorescein staining as reported by Bron et al [39].
- •Experienced 1 or more recurrences of VKC during the previous year
排除标准
- •Nasolacrimal duct obstruction
- •Impaired blinking function
- •Active ocular infection or history of ocular herpes, varicella zoster or vaccinia virus infection
- •Any ocular disease that would require topical ocular treatment during the study
- •Use of cyclosporin A or tacrolimus eyedrops, or use of systemic immunosuppressants within 3 months before enrolment
- •Any ocular surgery within 6 months before enrolment
研究组 & 干预措施
3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion
3% Diquafosol eyedrops 6x/day + 0.1% Cyclosporin A twice a day
干预措施: 3% Diquafosol ophthalmic solution and 0.1% Cyclosporin A cationic ophthalmic emulsion (Drug)
0.1% Cyclosporin A cationic ophthalmic emulsion
0.1% Cyclosporin A eyedrops twice a day + preservative free sodium hyaluronate eyedrops 6x/day
干预措施: 0.1% Cyclosporin A cationic ophthalmic emulsion (Drug)
结局指标
主要结局
Change in Cornea Fluorescein Staining (CFS) score from baseline to 4 weeks, 8 weeks and 16 weeks between study groups
时间窗: From baseline to 4 months post- treatment between study groups
Higher values mean inferior outcomes. Graded according to the modified Oxford grading scale (range 0, 0.5, 1, 2, 3, 4, 5). A difference in score of at least 2 levels (i.e. 4 to 2) or complete resolution of staining (i.e. 0) are both considered clinically significant endpoints.
次要结局
- Percentage of patients requiring rescue topical steroid therapy at 4 weeks, 8 weeks and 16 weeks(From baseline to 4 months post- treatment between study groups)
- Percentage of patients with improvement in Cornea Fluorescein Staining (CSF) at 4 weeks, 8 weeks and 16 weeks(From baseline to 4 months post- treatment between study groups)
- Change in best corrected visual acuity from baseline to 4 weeks, 8 weeks and 16 weeks(From baseline to 4 months post- treatment between study groups)
- Change in Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) score from baseline to 4 weeks, 8 weeks and 16 weeks(From baseline to 4 months post- treatment between study groups)
- Change in Quality of Life in Children with Vernal Keratoconjunctivitis (QUICK) score from baseline to 4 weeks, 8 weeks and 16 weeks(From baseline to 4 months post- treatment between study groups)
- Change in NIKBUT from baseline to 4 weeks, 8 weeks and 16 weeks(From baseline to 4 months post- treatment between study groups)
- Change in tear meniscus height from baseline to 4 weeks, 8 weeks and 16 weeks(From baseline to 4 months post- treatment between study groups)
- Change in tear cytokines from baseline to 4 weeks, 8 weeks and 16 weeks(From baseline to 4 months post- treatment between study groups)