A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 427
- 主要终点
- Mean change from baseline in sodium fluorescein corneal staining score
研究概览
简要总结
The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) ophthalmic gel compared to Vehicle for the treatment of dry eye.
详细描述
A 7-day Vehicle pre-randomization (run-in) phase during which all patients will receive 1 drop of Vehicle in each eye twice daily will precede the 21-day treatment phase, for an overall study duration of 28 days.
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)
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
- •Must read, sign, and date an informed consent document and HIPAA privacy document.
- •Diagnosis of dry eye at Visit 1 (Day 0).
- •Able and willing to follow study instructions.
- •Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Diagnosis of Sjogren's syndrome (or suspected to have Sjogren's syndrome).
- •History or evidence of ocular or intraocular surgery in either eye within the previous year.
- •History or evidence of serious ocular trauma in either eye within the previous 6 months.
- •History or evidence of corneal transplant or transplant variant procedures.
- •History of intolerance or hypersensitivity to any component of the study medications.
- •History of glaucoma or current ocular hypertension in either eye, or treatment for either condition within 6 months prior to Visit
- •History or evidence of corneal conditions, other than dry eye, that may affect the corneal structure.
- •Use of any concomitant topical ocular medications including artificial tears during the study period.
- •Females of childbearing potential if breastfeeding, unwilling to undergo urine pregnancy test at screening and upon exiting the study, have a positive urine pregnancy test at screening, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study.
- •Use of RESTASIS® 0.05% or an ocular steroid within 30 days of Visit
- •Use of systemic medications that have not been stable for 30 days prior to Visit
- •Any ocular condition that may preclude the safe administration of the test article.
- •Unwilling to discontinue contact lens wear at least 4 weeks prior to Visit 1, and during the study period.
- •Use of punctal plugs or punctal cautery.
- •Use of lid scrubs/warm compresses within 14 days of Visit
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
HPGG 0.25%
Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase).
干预措施: Hydroxypropyl Guar Galactomannan (HPGG) 0.25% ophthalmic gel (Drug)
HPGG Vehicle
Hydroxypropyl Guar Galactomannan Vehicle, 1 drop per eye twice daily (BID) (in the morning upon awakening and in the evening prior to bedtime) for 21 days (Treatment phase).
干预措施: Hydroxypropyl Guar Galactomannan Vehicle (Drug)
结局指标
主要结局
Mean change from baseline in sodium fluorescein corneal staining score
时间窗: Baseline (Day 7), Up to Day 28
次要结局
- Mean change from baseline in Dry Eye Symptom Questionnaire (OSDI) score(Baseline (Day 7), Up to Day 28)