A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Pro-ocular™ 0.5% and 1% in Patients With Dry Eye Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- SIFI SpA
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Corneal Fluorescein Staining
研究概览
简要总结
Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 clinical trial.
The study objective is to evaluate the safety and efficacy of two different concentrations (0.5% and 1%) of progesterone topical gel compared to placebo, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male or female) ≥ 18 years of age.
- •Able and willing to provide voluntary written Informed Consent prior to any study related procedure.
- •Patients must be diagnosed with any type of dry eye at least 3 months before screening (Visit 0).
- •Have all the following in the same eye at Visit 0:
- •Fluorescein staining (Cornea) on NEI (National Eye Institute) grading scale > 3
- •Average Tear Film Break up Time ≤ 5 seconds
- •Schirmer Test (without anesthesia) ≥ 1 and < 10mm
- •Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator.
排除标准
- •Comorbidity with other severe or chronic conditions that in the judgment of the investigator will interfere with study assessment, such as such as glaucoma, active neuronal trigeminal disease, neuralgia.
- •Best corrected visual acuity (BCVA) baseline <20/
- •Condition or history other than ocular that, in the opinion of the investigator, may interfere significantly with the patient's participation in the study, such as dementia, psychosis, Parkinson's disease (interference).
- •Patient using a contact ocular lens within 7 days prior to administration of the first dose and not willing to cease using them during all study duration.
- •Female patients who are pregnant, nursing an infant, or planning a pregnancy or lactating at Screening Visit.
- •Females who are of childbearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable non-hormonal contraceptive precautions can be included (See Note A).
- •Males with partners who are pregnant or lactating or of childbearing potential and are unwilling to use condoms for the duration of the study.
- •A known adverse reaction and/or sensitivity to the study drug or its components.
- •Use of topical ocular cyclosporine, corticosteroids or any other topical anti-inflammatory treatments within 15 days prior to Visit 0 and during all study duration.
- •Routine use (more than twice a week) of a chlorinated swimming pool during the study period
- •Unwilling or unable to cease using during the study period the forbidden medications:
- •Any topical ocular ointments or gels
- •Topical and systemic glaucoma therapies
- •Systemic drugs with anticholinergic activity: anticonvulsants, antihistamines, antipsychotics, antidepressants, antimuscarinics, anti-Parkinson agents, cardiovascular agents (disopyramide), gastrointestinal agents, muscle relaxants, respiratory medications (pseudoephedrine, theophylline)
- •Lipidic artificial tears and artificial tears with preservative.
- •Unwilling to cease the use of sunscreen on the forehead or eye area during the study period.
- •Habitual cigarette smokers (tobacco, vapor cigarettes, marijuana), smoking more than 4 cigarettes per day.
- •Participation in another clinical study at the same time as the present and within 30 days prior to Visit 0.
研究组 & 干预措施
Pro-ocular™ 1% Progesterone EP topical gel
Multidose formulation despensing unit doses of 0.07 g of topical gel containing 0.7 mg of progesterone
干预措施: Pro-ocular gel (Drug)
Pro-ocular™ 0.5% Progesterone EP topical gel
Multidose formulation despensing unit doses of 0.07 g of topical gel containing 0.35 mg of progesterone
干预措施: Pro-ocular gel (Drug)
Placebo topical gel
Multidose formulation identical in appearance to Experimental Products despensing unit doses of 0.07 g of topical gel containing 0 mg of progesterone
干预措施: Placebo gel (Drug)
结局指标
主要结局
Corneal Fluorescein Staining
时间窗: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)
Mean change from baseline (Visit 1 pre-dose) in corneal fluorescein staining assessed by NEI scale at Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)
SANDE questionnaire
时间窗: Week 12 (Day 84) (with Last Observation Carried Forward (LOCF) imputation)
Mean change from baseline (Visit 1 pre-dose) in sum of frequency and intensity of dryness/irritation patient feeling assessed by SANDE questionnaire at Week 12 (Day 84) (with LOCF imputation)
次要结局
- SANDE questionnaire(Week 2, 4, 8, 16 (Day 14, 28, 56,114))
- Non-Invasive Keratograph Tear Film Break Up (NIKBUT) Time (NIKBUT)(Week 2, 4, 8, 12 (Day 14, 28, 56, 84))
- Dry Eye-Related Quality-of-Life (DEQS) questionnaire(Each applicable post baseline visit)
- Corneal fluorescein staining(Week 2, 4, 8 (Day 14, 28, 56))
- Fluorescein Tear Film Break Up Time (TBUT)(Week 12 (Day 84))
- Slit Lamp Examination(Week 2, 4, 8, 12 (Day 14, 28, 56, 84))
- Tear meniscus height (TMH)(Week 2, 4, 8, 12 (Day 14, 28, 56, 84)])
- Corneal Sensitivity(Week 4, 12 (Day 28, 84))
- Conjunctival fluorescein staining(Week 2, 4, 8 (Day 14, 28, 56))
- Schirmer test(Week 4 (Day 28) and Week 12 (Day 84))
- Visual Analogue Scale(Week 2, 4, 8, 12 (Day 14, 28, 56, 84))