NL-OMON38494已完成4 期
Evaluation of Clinical Outcomes Following Treatment with Systane® Balance in Dry Eye Subjects with Lipid Deficiency - Clinical Outcomes Following Treatment with Systane Balance of Dry Eye
Alcon Laboratories0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Willing and able to attend all study visits
- •2. Must have all of the following in at least 1 eye at Screening (Day -15):
- •a. Meibomian Gland Dysfunction (MGD) grading for Expressibility * 2 and Meibum Quality * 2,
- •b. The average of 3 measures of TFBUT < 5 seconds, and
- •c. Unanesthetized Schirmer I test of * 3 mm
- •3. Must have an Ocular Surface Disease Index (OSDI) Score * 18 at Visit 1 (Day 0) prior to randomization (ie, after 2 weeks of run-in with Preservative-Free 0.9% Saline administered 4 times a day)
- •4. Must have best-corrected visual acuity of 55 letters or better in each eye as assessed using an ETDRS chart (letter read method)
- •5. Physician diagnosis of dry eye at least 6 months prior to Screening visit
- •6. Must be at least 18 years old and able to provide written informed consent
排除标准
- •1. Subjects on topical ocular treatments containing benzalkonium chloride (BAK), or other products with known toxicity to the corneal surface, within 30 days of Screening
- •2. Subjects who have started, stopped, or changed a lid hygiene regimen within 30 days of Screening. Note: Subjects who have been on a consistent lid hygiene regimen (ie, no change to the type of lid hygiene therapy that is being used as well as the frequency of use) for at least 30 days prior to Screening are not excluded. However, they cannot stop or change this regimen for the
- •duration of the study. In addition, subjects who do not currently use lid hygiene therapy cannot start for the duration of the study.
- •3. Use of any artificial tears/lubricants/gels/rewetting drops within 4 hours of Screening
- •4. Women of childbearing potential (those who are not surgically sterilized or postmenopausal for at least 2 years) are excluded from participating in this study if they meet any of the following conditions:
- •* They are currently pregnant, or
- •* Test positive for pregnancy at Screening visit, or
- •* They are currently breast feeding, or
- •* Are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
- •5. Hypersensitivity to the use of any of the study products or allergy to any ingredient in the study products
- •6. Has an active ocular allergy
- •7. Ocular abnormalities that could adversely affect the safety or efficacy outcome such as:
- •* Eyelid anomalies that affect proper lid closure or proper blink function (eg, ectropion, entropion,
- •trichiasis, lid margin lesions, tarsal plate pathology, unresolved Bell*s palsy, etc.)
- •* Evidence of benign hemifacial spasm, benign essential blepharospasm, or eyelid apraxia
- •* Corneal disorders or abnormality such as active corneal ulcer, current corneal abrasion, keratoconus or corneal dystrophies which are actively changing or affect vision
- •* Metaplasia of the ocular surface
- •* History of corneal erosion syndrome or recurrent corneal erosion syndrome
- •* Clinically significant corneal epithelial anterior membrane dystrophy (subjects with
- •minor/insignificant predominantly peripheral corneal epithelial dystrophy [not central dystrophy] without a history of corneal erosion syndrome can be included)
- •* Current filamentous keratitis
- •* Evidence of corneal neovascularization
- •* Any history of Herpes Simplex or Herpes Zoster Keratitis
- •8. Subjects taking any systemic medication known to cause dry eye (eg, anti-histamines, anti-depressants, antipsychotics, etc.) unless they have been on stable therapy/dosage for at least 30 days prior to Screening and will remain on a stable dosage for the duration of the study
- •9. Subjects with a history of any ocular or intraocular surgery (including periocular Botox injections), eyelid surgery, keratorefractive procedure, corneal transplant and its variants (eg, penetrating keratoplasty, DSEK, DMEK, DSAEK, DALK), or serious ocular trauma within 1 year of Screening
- •10. Active ocular infection (bacterial, viral or fungal), active inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc
- •11. Subjects with punctal plug insertion or diathermy procedure initiated within 30 days of Screening
- •12. Have any significant illnesses that could, in the opinion of the Investigator, be expected to interfere with the study parameters
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