NCT04702776已完成4 期
Non Inferiority Phase IV Clinical Study, to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF Against Hyabak® and Lagricel Ofteno® PF When Applied on the Ocular Surface of Patients With Mild to Moderate Dry Eye.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index (OSDI)
研究概览
简要总结
Phase IV, non inferiority, controlled, open, multicenter clinical study to compare the efficacy of the Ophthalmic Solution Humylub Ofteno® PF against Hyabak® and Lagricel Ofteno® PF applied quater in die (QID) for 30 days in patients with mild to moderate dry eye disease.
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
After signing the informed consent form (ICF), every subject will receive a coded patient number and will be assigned randomly to one of the investigation products.
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
- •Being capable of voluntarily grant a signed informed consent.
- •Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
- •Age ≥ 18 years old
- •Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.
- •Presenting a mild to moderate dry eye disease diagnosis, defined as:
- •OSDI score ≥ 13, plus one of the following:
- •More than 5 dots of corneal staining
- •More than 9 dots of conjunctival staining
- •Tear break-up time < 10 seconds
排除标准
- •- Pregnancy, breastfeeding or planning to become pregnant during the time of the study
- •Having participated in clinical trials within 30 days prior to the eligibility visit.
- •Having participated previously in this study.
- •BCVA equal or worse than 20/200, in either eye.
- •Diagnosis of any of the following:
- •Allergic, viral or bacterial conjunctivitis
- •Anterior blepharitis
- •Parasite infestation of any ocular or annex structures (Demodex, for example)
- •Unresolved history of ocular trauma
- •Scarring diseases of the ocular surface
- •Corneal or conjunctival ulcers
- •Filamentary keratitis
- •Neurotrophic keratitis
- •Bullous keratopathy
- •Neoplastic diseases of the ocular surface or ocular annexes
- •Diseases presenting fibrovascular proliferations on the corneal or conjunctival surface.
- •Any retinal or posterior segment diseases that require treatment or threat the visual outcome.
- •Any palpebral alteration that causes eyelid malposition, limiting the adequate closure or aperture of this structures, or that cause tearing.
- •Requiring management for dry eye that includes implementation of treatments described in the step 2 management recommendations of the Tear Film & Ocular Surface Society's Dry Eye Work Shop II (TFO DEWS II).
- •Previous history of drug addiction within the last 2 years prior to signing this study's informed consent form.
- •Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date.
- •Being a contact lens user, rigid or soft. Inclusion is possible if the use of contact lenses is suspended both during the study period and at least 15 days prior inclusion takes place.
- •Previous history of any medical affliction, acute or chronic, that according to the investigator may increase either the risk to the patient for participating in this study or the risk of interference of the accurate interpretation of results.
- •Known hypersensitivity to any of the components of the products used in this study.
研究组 & 干预措施
Arm 1; Humylub Ofteno® PF
Experimental
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
干预措施: Sodium hyaluronate 0.1%/chondroitin sulfate 0.18% (Drug)
Arm 2; Hyabak®
Active Comparator
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
干预措施: Sodium hyaluronate 0.15% (Drug)
Arm 3; Lagricel Ofteno® PF
Active Comparator
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
干预措施: Sodium hyaluronate 0.4% (Drug)
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI)
时间窗: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
OSDI is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). A higher score is a worse outcome. • This outcome measure considered the Per Protocol (PP) population.
次要结局
- Noninvasive Keratograph Break-up Time (NIKBUT)(Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Change of Conjunctival and Corneal Staining With Lissamine Green(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Change of Conjunctival and Corneal Staining With Fluorescein(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Change in Conjunctival Hyperemia(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Incidence of Related Non Expected Adverse Events(Days: 0 (eligibility visit), 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), 31 - 33 (± 1) (final visit), and 38 - 40 (± 1) (safety call).)
- Change in Best Corrected Visual Acuity (BCVA)(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Change in Incidence of Chemosis(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
研究者
研究点 (1)
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