CTRI/2014/12/005323已完成未知
A prospective, open label study to evaluate the Intraocular Pressure lowering effect of 0.15% (w/v) Forskolin aqueous solution in patients with ocular hypertension or mild open angle glaucoma
Sami labs Limited0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
入选标准
- •1 Male and female subjects greater than 18 years of age
- •2 Willingness to comply with the investigators and protocols instructions
- •3 Patients signature on the informed consent document
- •4 Have a clinical diagnosis of bilateral or unilateral mild primary open-angle and pigmentary or pseudo exfoliation glaucoma and ocular hypertension
- •5 Patients currently on no topical IOP lowering medication or patients with IOP controlled on one IOP lowering medication
- •6 At screening the intraocular pressure must be considered to be safe in such a way that should assure clinical stability of vision and the optic nerve throughout the trial
- •7 Snellen visual acuity must be 0.4 or better in both eyes
排除标准
- •1 Any abnormality preventing reliable applanation tonometry
- •2 Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber
- •3 Any concurrent infectious or noninfectious conjunctivitis and keratitis or uveitis in either eye
- •4 Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
- •5 Females of childbearing potential not using reliable means of birth control
- •6 Pregnant or lactating females
- •7 Participation or current participation in any investigational drug or device trial within the previous 30 days prior to Screening
- •8 According to the investigators best judgment risk of visual field or visual acuity worsening as a consequence of participation in the trial
- •9 Inability to understand the trial procedures and thus inability to give informed consent
- •10 Any clinically significant serious or severe medical or psychiatric condition that in the investigators opinion may result in poor compliance with the study protocol and or may increase the likelihood of any adverse event related to any of the study medications
- •11 Any anticipated change during active treatment phase of this study in systemic hypertensive therapy during the trial which might include adjustments to oral Ã? adrenergic blockers and alpha agonists and blockers and angiotensin converting enzyme inhibitors and calcium channel blockers
- •12 Progressive retinal or optic nerve disease apart from glaucoma
- •13 History of ocular herpes simplex, cystoids macular edema or uveitis
- •14 Use of chronic corticosteroids by any route
- •15 Previous glaucoma filtering surgery within the last 6 months
- •16 Subjects who have undergone Argon Laser Trabeculoplasty or Selective Laser Trabeculoplasty or laser iridotomy in the past 3 months
研究者
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