Patient Satisfaction With Timolol Maleate in Sorbate, Generic Timolol Gel Forming Solution or Timolol Hemihydrate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Stinging on Instillation
研究概览
简要总结
This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willing to comply with investigator's and protocol's instructions
- •patients signature on the informed consent document
- •primary open-angle glaucoma, pigment dispersion or exfoliation glaucoma, or ocular hypertension in at least one eye
- •at screening intraocular pressure must be considered to be safe, in both eyes
- •in non-qualifying eyes the intraocular pressure should be able to be controlled safely on no pharmacologic therapy or on study medicine alone
- •currently treated with one glaucoma medication, untreated intraocular pressure of less than or equal to 28 mm Hg at visit 2 in both eyes
排除标准
- •any abnormality preventing reliable applanation tonometry in either eye
- •any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber in either eye
- •any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye
- •any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
- •females of childbearing potential not using reliable means of birth control
- •pregnant or lactating females
- •any clinically significant, serious, or severe medical or psychiatric condition
- •participation (or current participation) in any investigational drug or device trial within 30 days prior to Visit 1
- •severe prior visual acuity or field loss from any cause
- •inability to understand the trial procedures, and thus inability to give informed consent
- •progressive retinal or optic nerve disease apart from glaucoma
- •serious systemic or ocular disease
- •intraocular laser surgery within the past three months or corneal or intraocular conventional surgery within the past 6 months
- •concurrent use of systemic corticosteroids, by IV, oral, dermal or topical ophthalmic route.
- •subjects requiring tear replacement drops or allergy medications with sympathomimetics 24 hours prior to a scheduled study visit
- •contraindication to beta-blocker usage including: reactive airway disease, uncontrolled heart failure, or second as well as third degree cardiac block, myasthenia gravis
- •any subject the investigator believes will be at risk for glaucomatous progression by their participation in this trial
研究组 & 干预措施
hemihydrate/maleate/maleate gel
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
干预措施: Timolol Maleate in Sorbate (Drug)
hemihydrate/maleate/maleate gel
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
干预措施: Timolol hemihydrate (Drug)
hemihydrate/maleate/maleate gel
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
干预措施: Timolol maleate gel forming solution (Drug)
maleate/maleate gel/hemihydrate
Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
干预措施: Timolol Maleate in Sorbate (Drug)
maleate/maleate gel/hemihydrate
Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
干预措施: Timolol hemihydrate (Drug)
maleate/maleate gel/hemihydrate
Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
干预措施: Timolol maleate gel forming solution (Drug)
maleate gel/hemihydrate/maleate
Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
干预措施: Timolol Maleate in Sorbate (Drug)
maleate gel/hemihydrate/maleate
Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
干预措施: Timolol hemihydrate (Drug)
maleate gel/hemihydrate/maleate
Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
干预措施: Timolol maleate gel forming solution (Drug)
hemihydrate/maleate gel/maleate
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
干预措施: Timolol Maleate in Sorbate (Drug)
hemihydrate/maleate gel/maleate
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
干预措施: Timolol hemihydrate (Drug)
hemihydrate/maleate gel/maleate
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
干预措施: Timolol maleate gel forming solution (Drug)
maleate/hemihydrate/maleate gel
Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
干预措施: Timolol Maleate in Sorbate (Drug)
maleate/hemihydrate/maleate gel
Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
干预措施: Timolol hemihydrate (Drug)
maleate/hemihydrate/maleate gel
Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
干预措施: Timolol maleate gel forming solution (Drug)
maleate gel, maleate, hemihydrate
Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
干预措施: Timolol Maleate in Sorbate (Drug)
maleate gel, maleate, hemihydrate
Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
干预措施: Timolol hemihydrate (Drug)
maleate gel, maleate, hemihydrate
Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
干预措施: Timolol maleate gel forming solution (Drug)
结局指标
主要结局
Stinging on Instillation
时间窗: following 3 days of treatment
Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.
次要结局
- Conjunctival Hyperemia(following 3 days of treatment)
- Tear Film Break-up Time(following 3 days of treatment)
- Corneal Staining Grade(following 3 days of treatment)
- Corneal Staining Count(following 3 days of treatment)
- Intraoclular Pressure(following 3 days of treatment)
- Basic Schirmer's(following 3 days of treatment)
- Conjunctival Staining - Nasal Grade(following 3 days of treatment)
- Conjunctival Staining - Nasal Count(following 3 days of treatment)
- Visual Acuity(following 3 days of treatment)
- Conjunctival Staining - Temporal Grade(following 3 days of treatment)
- Conjunctival Staining - Temporal Count(following 3 days of treatment)