Phase II Clinical Study to Evaluate the Efficacy of Multidose Lagricel® Ofteno Ophthalmic Solution Applied in Three Different Dosage Schemes as Treatment for Mild to Moderate Dry Eye
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 141
- 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 II, comparative, controlled, multicenter, parallel group, open, randomized clinical study. The main outcome variable will be the Ocular Surface Disease Index (OSDI) questionnaire. Three dosage schemes of topical ophthalmic application of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%; preservative free) are to be evaluated in patients diagnosed with mild to severe dry eye. Each group will be exposed to one of the following administration schemes: 1 drop bis in die (BID), 1 drop quater in die (QID), or 1 drop six times per day; instillation will take place in both eyes (OU).
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
- None
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
- •Age ≥18 years old.
- •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.
- •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 between 13 and 32, plus one of the following:
- •More than 5 dots of corneal staining
- •More than 9 dots of conjunctival staining
- •Tear Break-up Time (BUT) < 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 signing this study's informed consent form.
- •Having participated previously in this study.
- •Best Corrected Visual Acuity (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 ocular 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.
- •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
Group 3
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) 6 times per day in OU during 30 days.
干预措施: Sodium Hyaluronate Ophthalmic 0.4% Six times per day (Drug)
Group 1
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop twice a day (BID) in both eyes (OU) during 30 days.
干预措施: Sodium Hyaluronate Ophthalmic 0.4% one drop twice a day (BID) (Drug)
Group 2
Application of one drop of Multidose Lagricel® Ofteno (Sodium Hyaluronate 0.4%) one drop four times a day (QID) in both eyes (OU) during 30 days.
干预措施: Sodium Hyaluronate Ophthalmic 0.4% one drop four times a day (QID) (Drug)
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI)
时间窗: Basal Visit (BV) (day 0) and Final Visit (FV) (day 31+1,).
OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale. The OSDI score ranges from 0 to 100, with higher scores indicating greater severity of symptoms. A score of 0 represents no symptoms, while 100 represents the most severe symptoms.
Incidence of Adverse Events (AE)
时间窗: Up to Day 33 (+ 1) (safety call).
Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution and whether it was considered related or not to the investigation products.
次要结局
- Change in Tear Break-up Time (BUT)(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Conjunctival and Corneal Staining With Lissamine Green(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Conjunctival and Corneal Staining With Fluorescein(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Conjunctival Hyperemia(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Incidence of Chemosis(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Best Corrected Visual Acuity (BCVA)(Baseline Visit (BV) (day 0,), Fisrt follow-up visit (V1) (day 15±1), and Final Visit (FV) (day 31+1).)
- Change in Intraocular Pressure (IOP)(BV (day 0, baseline visit), V1 (day 15±1, first follow-up visit), and FV (day 31+1, final visit).)