CTRI/2020/01/022887进行中（未招募）3 期
A randomized, double-blind and multicenter study to compare the efficacy and safety of topical Forskolin (0.15%) and topical Timolol (0.5%) in patients with ocular hypertension or open angle glaucoma.
SamiSabinsa Group Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
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. Newly diagnosed with ocular hypertension or open angle glaucoma.
- •2. Non-medicated IOP is equal to or greater than 22mmHg and less than 30mmHg in one or both eyes.
- •3. Patients currently on no topical IOP lowering medication.
- •4. 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.
- •5. Snellen visual acuity must be 6/12 or better in both eyes.
- •6.Willingness to comply with the investigators and protocol instruction.
- •7. > 18 years of age (male and female adult subjects).
- •8.Patient signature on the informed consent document [each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form.
排除标准
- •1.Any abnormality preventing reliable Applanation Tonometry.
- •2.Diagnosed with advanced stage of glaucoma
- •3.Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
- •4.A person having only one eye (anopthalmia) & sight in a single eye.
- •5.Progressive retinal or optic nerve disease apart from glaucoma.
- •6.Previous glaucoma filtering surgery
- •7.Subjects who have undergone Argon Laser Trabeculoplasty (ALT) or Selective Laser Trabeculoplasty (SLT) or laser iridotomy
- •8.Any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- •9.Any clinically significant, serious, or severe medical or psychiatric condition that in the investigatorââ?¬•s 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.
- •10.Any anticipated change during active treatment phase of this study in systemic hypertensive therapy during the trial which might include adjustments to oral Ã?Ÿ - adrenergic blockers, ï?¡-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers.
- •11.History of ocular herpes simplex, cystoids macular edema or uveitis.
- •12.Use of chronic corticosteroids by any route.
- •13.According to the investigatorââ?¬•s best judgment, risk of visual field or visual acuity worsening as a consequence of participation in the trial.
- •14.Females of childbearing potential not using reliable means of birth control.
- •15.Pregnant or lactating females.
- •16.Inability to understand the trial procedures, and thus inability to give informed consent.
- •17.Any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial.
- •18.Participation (or current participation) in any investigational drug or device trial within the previous 30 days prior to screening.
研究者
相似试验
招募中
3 期
Phase III clinical study of DRL Abatacept (DRL_AB) and Orencia in Rheumatoid Arthritis patientCTRI/2024/03/064580Dr. Reddys Laboratories Ltd.
招募中
1 期
A randomised, double-blind, multicentre study comparing the efficacy, safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia® administered by the intravenous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritisMedDRA version: 23.1Level: LLTClassification code: 10039074Term: Rheumatoid arthritis aggravated Class: 10028395MedDRA version: 23.1Level: PTClassification code: 10039073Term: Rheumatoid arthritis Class: 100000004859MedDRA version: 23.1Level: LLTClassification code: 10066578Term: Progression of rheumatoid arthritis Class: 10028395MedDRA version: 20.0Level: HLTClassification code: 10039075Term: Rheumatoid arthritis and associated conditions Class: 10021428Rheumatoid ArthritisCTIS2023-506664-14-00Dr Reddy's Laboratories Limited532
尚未招募
4 期
A multicenter, randomized, double-blind study on the efficacy and safety of Gongxuening capsules in reducing postoperative bleeding after induced abortiopostoperative bleeding after induced abortionITMCTR2200005956Peking Union Medical College Hospital
进行中（未招募）
不适用
A double-blind, randomized, multi-center study with 500 mg QD of TRO19622 versus placebo in patients with painful peripheral diabetic neuropathyEUCTR2006-004545-42-LVTROPHOS180
进行中（未招募）
不适用
A double-blind, randomized, multi-center study with 500 mg QD of TRO19622 versus placebo in patients with painful peripheral diabetic neuropathyEUCTR2006-004545-42-DETROPHOS180