Efficacy and Safety of the Ophthalmic Solution PRO-087 Versus Systane ® Ultra and Systane ® Ultra Preservative Free on Tear Film Dysfunction Syndrome From Mild to Moderate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
Efficacy and Safety of the Ophthalmic Solution PRO-087 versus Systane ® Ultra and Systane ® Ultra Preservative Free on the Tear Film Dysfunction Syndrome from Mild to Moderate Clinical trial To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological characteristics of the ocular surface, as well as its distribution and the characteristics of the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).
Controlled, randomized, double-blind, masked clinical study, comparing the safety and efficacy of preservative-free PR0-087 vs Systane Ultra with preservative and Systane Ultra preservative free, in subjects with mild to moderate tear film dysfunction syndrome, for a period of 90 days plus 15 days of remote surveillance, in which one of the three agents will be administered (PR0-087, Systane® Ultra or Systane® Ultra preservative free) with a q.i.d. dosage. in both eyes, with regular follow-up visits (5 overall).
Best-corrected visual acuity Intraocular pressure Ocular surface Anterior segment examination Posterior segment examination Tear film break-up time Schirmer test Corneal epithelization Goblet cells count Adverse events Subjects with a clinical diagnosis of mild to moderate tear film dysfunction syndrome between 18 and 90 years old, without concomitant eye diseases nor requiring different treatments of any of the three interventions in this study They will be randomized in 3 groups where PRO-087, Systane® Ultra o Systane® Ultra preservative free will be administered.
详细描述
Design Controlled, double-blind, randomized, clinical trial comparing the safety and efficacy parameters between a group of subjects with a diagnose of mild to moderate tear film dysfunction syndrome under a regimen of ophthalmic solution lubricant drops PRO-087 versus subject under Systane® Ultra or Systane® Ultra preservative free, with the same diagnosis, with a follow-up of 90 days
MAIN OBJECTIVE:
To evaluate the effectiveness of preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) to restore the anatomical and physiological characteristics of the ocular surface, as well as its distribution and the characteristics of the mild to moderate tear film dysfunction syndrome compared to Systane ® Ultra and Ultra Systane ® preservative free (by Laboratorios Alcon, S.A. de C.V.).
SPECIFIC OBJECTIVES:
To evaluate the safety of the preservative-free ophthalmic formulation PRO-087 (by Laboratorios Sophia, S.A. de C.V.) on the corneal and conjunctival epithelium, intraocular pressure, and structures of anterior and posterior segment in patients with tear film dysfunction syndrome from mild to moderate.
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
The double-blind study is a procedure in which the patient and the treating doctor ignore to which intervention group the study patient was assigned. To achieve the blinding of both the drug in research and both comparator drugs, these will be labeled in the same way (masking). Besides the figure of an unblinded pharmacist, who is responsible for the delivery of the medication to the patient, will be added. Blinding codes are protected by an outsider appointed by the study sponsor. The codes are also available in the research center (fully sealed), so that they can be consulted by the investigator in case a subject presents a serious adverse event, prior authorization from the study sponsor; the blinding also continues rigorous during the data analysis and interpretation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 to < 90 years old
- •Both sexes
- •Mild to moderate tear film dysfunction clinical diagnose
- •Mild to moderate clinical stage of the disease
- •TBUT > 5 sec. and < 10 sec.
- •Schirmer: > 4 mm and < 14 mm
- •OSDI < 30 points
- •Corneal staining < grade III on the Oxford scale
- •Availability to go to each revision when indicated.
排除标准
- •General Criteria
- •Subjects with topical and/or systemic medication or mechanical devices that interfere determinedly on the results of the study (such as topical immunomodulators, punctal plugs, corticosteroids, preservative artificial tears, contact lenses).
- •Subjects (females) with active sexual life that do not use a contraceptive method.
- •Female subjects who are pregnant or lactating
- •Female subjects with a positive urine pregnancy test
- •Positive drug addictions* (verbal interrogatory)
- •Subjects who have participated on any other research clinical trials on the last 40 days
- •Subjects legal or mentally disabled to give an informed consent for participating on this study
- •Subjects who can't comply with the appointments or with every protocol requirement.
- •Criteria related with ophthalmic ailments
- •Serious tear film dysfunction syndrome TBUT < 5 s Schirmer: < 4 mm OSDI > 30 pints Corneal staining > grade III on the Oxford scale
- •Non perforated corneal ulcer
- •Perforated corneal ulcer
- •Autoimmune corneal ulcer
- •Ocular surface scarring diseases
- •Ocular surface or annexes metaplastic lesions
- •Fibro vascular proliferation lesions on the conjunctival and/or corneal surface (i.e.: pterygium)
- •Concomitant chronic inflammatory diseases on any ocular structure
- •Acute or infectious inflammatory disease
- •Corneal disease potentially requiring a treatment during the following 3 months
- •Use of topical or systemic drug products classified as forbidden
- •Ocular surgical procedures 3 months before the protocol inclusion
- •Treatments or procedures indicated on the tear film dysfunction treatment, as punctal silicone plugs.
- •Posterior segment diseases requiring a treatment or threatening the visual prognosis
- •Retinal diseases potentially requiring treatment during the following 3 months
- •History of penetrating keratoplasty.
- •Soft or hard contact lenses use during the last month from inclusion day
研究组 & 干预措施
PRO-087 PF
Preservative free (PF) PRO-087 ophthalmic solution. Dropper bottle. Multidose 1 drop every 4 hours for 90 days.
干预措施: PRO-087 (Drug)
Systane Ultra
Systane Ultra ophthalmic solution, Dropper bottle, Multidose.
1 drop every 4 hours for 90 days.
干预措施: Systane Ultra (Drug)
Systane Ultra PF
Systane Ultra, preservative free ophthalmic solution, single-use vials.
1 drop every 4 hours for 90 days.
干预措施: Systane Ultra Preservative Free (Drug)
结局指标
主要结局
Visual Acuity
时间窗: Change from Baseline visual acuity at 90 days
Best-corrected visual acuity
次要结局
- Corneal Epithelization Defects With Rose of Bengal(Final Visit (day 90))
- Schirmer Test(Base line and Final Visit (day 90))
- Adverse Events(90 days)
- Goblet Cells Population(Change from Baseline Goblet cells population at 90 days)
- Tear Film Break-up Time (TBUT)(Base line and Final Visit (day 90))
- Corneal Epithelization Defects With Fluorescein(Final Visit (day 90))
- Ocular Surface Disease Index (OSDI)(Change from Baseline OSDI at 90 days)