NCT04685109进行中（未招募）不适用
A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study in Adult Patients With Moderate to Severe Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Santen SAS
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Change of ocular surface staining (OSS) score between baseline and Day 28.
研究概览
简要总结
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is conducted at a national level, in France.
The patients will be randomised to receive ALOCROSS® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion
详细描述
Primary:
• To compare the ocular efficacy of ALOCROSS® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis after a 4-week treatment period (Day 28).
Secondary:
- To compare the ocular efficacy of ALOCROSS® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis over a 12-week treatment period
- To evaluate the ocular tolerability and safety of ALOCROSS® versus VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis throughout the duration of treatment
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)
盲法说明
Investigator Masked, unmasked Pharmacist
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
- •Patient eligibility is determined according to the following criteria:
- •Male or female patient aged 18 years or above.
- •Patient using artificial tears for at least 3 months prior to the Screening visit.
- •Patient experiencing at least 2 symptoms of ocular discomfort rated ≥23 mm on the 0 to 100 mm visual analogue scale (VAS) (among itching, eye dryness, sticky feeling, photophobia, pain, burning or stinging, sandy feeling or grittiness, or foreign body sensation) at Screening and Baseline visits.
- •OSS score (sum of nasal and temporal interpalpebral conjunctival and corneal vital staining) ≥4 and ≤9 on a modified Oxford scale at Screening and Baseline visits in at least one eye.
- •TBUT of ≤10 seconds at Screening and Baseline visits and/or Schirmer's tear test of ≥3 and ≤9 mm/5 min at Screening visit in the same eye that fulfil inclusion criteria #
- •The patient has signed and dated a written informed consent form prior to the initiation of any study procedures.
排除标准
- •Any patient who meets any of the following criteria (in any eye) will not qualify for entry into the study:
- •CFS score ≥4 on a modified Oxford scale
- •Ocular hypertension or glaucoma requiring IOP-lowering medication(s)
- •History of ocular trauma, infection or ocular inflammatory condition within the last 3 months before the screening visit.
- •Severe blepharitis and/or severe meibomian gland disease
- •Filamentary keratitis
- •Any ocular surface anomaly not related to DED
- •Active ocular infection or history of ocular allergy or ocular herpes
- •Patient with only one sighted eye or with a best corrected distance visual acuity ≤1/10
- •Use of any topical ocular treatment other than study device during the study (all non-study topical ocular treatment(s) must be stopped at the screening visit)
- •Onset of lid hygiene (whatever the method) less than 2 months before the Screening visit
- •Use of topical corticosteroids one month before the Screening Visit
- •Use of isotretinoin, ciclosporin, tacrolimus, sirolimus, pimecrolimus or ocular cauterisation procedures 2 months before the screening visit and throughout the study
- •Use of VISMED® within 6 weeks prior to the screening visit
- •Refractive surgery (e.g. LASIK, LASEK, PRK) within 6 months and/or any other ocular laser/surgery within 3 months prior to the screening visit and during the study
- •Insertion of temporary punctal plug(s) within 2 months prior to the Screening visit or permanent occlusion of lacrimal puncta on one or both sides
- •Known hypersensitivity to any of the components of the study device or investigational products Non-ocular
- •History of severe systemic allergy
- •Systemic disease not stabilised within 1 month prior to the screening visit (e.g. diabetes with glycaemia out of range, thyroid dysfunction) or judged by the investigator to be incompatible with the conduct of the study procedures or the interpretation of the study results
- •Any change of systemic concomitant medication within the month before the screening visit or planned change during the study period, except paracetamol
- •Pregnancy or lactation at the screening and/or Baseline visit.
- •Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomised partner) from the Baseline visit throughout the conduct of the study treatment periods and up to 2 weeks after the study end. Post-menopausal women (two years without menstruation) do not need to use any method of birth control.
- •Participation in a clinical trial with an investigational substance within the past 30 days prior to Baseline visit.
- •Participation in another clinical study at the same time as the present study.
结局指标
主要结局
Change of ocular surface staining (OSS) score between baseline and Day 28.
时间窗: Between Baseline and day 28
The primary endpoint of the study is the difference between patients treated with ALOCROSS® and patients treated with VISMED® in the change of ocular surface staining (OSS) score between baseline and D28. An OSS higher than 0 is considered to be abnormal and may be a sign of KCS. But scores of 1 or 2 can also represent a late staining artifact if interpretation of the fluorescein corneal staining pattern is delayed beyond 8 minutes. Because this could lead to a high level of misclassification, an abnormal OSS is defined as being a score of 3 or above.
次要结局
- Change of ocular surface staining (OSS) score between baseline and Day 84(between baseline and Day 14 and between baseline and Day 84)
- The change of ocular stainings (corneal fluorescein staining (CFS) and clearing and conjunctival staining) between baseline and Day 28 and between baseline and Day 84(between baseline and Day 28 and between baseline and Day 84)
- The change of ocular discomfort symptoms on Visual Analogue Scale(between baseline and Day 28 and between baseline and Day 84)
- The change tear breakup time (TBUT)(between baseline and Day 28 and between baseline and Day 84)
- The change in Schirmer's tear test(between baseline and Day 28 and between baseline and Day 84)
- The difference between patients treated with ALOCROSS® and patients treated with VISMED® in:(between baseline and Day 84)
- The secondary endpoints are the difference between patients treated with ALOCROSS® and patients treated with VISMED® in:(after 12 weeks of treatment (84 days))
研究者
研究点 (7)
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