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Glaucoma, Open-Angle clinical trials

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NCT ID: NCT02928289 Terminated - Open-Angle Glaucoma Clinical Trials

Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)

Start date: January 23, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.

NCT ID: NCT02891317 Terminated - Cataract Clinical Trials

Assessing Ocular Hemodynamic Response to Surgical Intervention in Glaucoma

Start date: May 8, 2017
Phase:
Study type: Observational

The purpose of this study is to assess how surgical interventions in glaucoma affect 24-hour intraocular pressure, 24-hour ocular perfusion pressure, optic nerve blood flow, and retinal oxygen saturation.

NCT ID: NCT02858284 Terminated - Ocular Hypertension Clinical Trials

Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension

Start date: July 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether the TUG device is safe and effective in patients with primary open angle glaucoma or ocular hypertension.

NCT ID: NCT02801617 Terminated - Ocular Hypertension Clinical Trials

Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension

COMPLIANCE
Start date: September 2015
Phase: Phase 3
Study type: Interventional

Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensive therapy in subjects with primary open angle glaucoma or ocular hypertension. Study design: a multicentric, prospective, crossover (2x2), double blind clinical study. Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension. Patients in the period 1: In the first sequence 60 patients will be assigned to receive the ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop per day (QD) during 30 days and the second sequence 60 patients will be assigned to receive the ophthalmic solution: PRO-067 1 drop QD during 30 days in the same period. Washout period: 21 hours. Patients in the period 2: the pharmacological intervention change to the opposite therapy for 30 days.

NCT ID: NCT02730871 Terminated - Ocular Hypertension Clinical Trials

Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®

Start date: June 24, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of Brinzolamide 1%/Brimonidine 0.2% (SIMBRINZA®) dosed twice daily (BID) when added to Travoprost 0.004%/Timolol 0.5% (DUOTRAV®) in subjects with open-angle glaucoma or ocular hypertension.

NCT ID: NCT02327312 Terminated - Clinical trials for Primary Open-Angle Glaucoma

Multicenter Investigation of Trabecular Micro-Bypass Stents vs. Laser Trabeculoplasty

Start date: December 16, 2014
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of Trabecular Micro-Bypass stents (two stents per study eye) vs. laser trabeculoplasty, in subjects with open angle glaucoma

NCT ID: NCT02226094 Terminated - Clinical trials for Ocular Hypertension (OHT)

Safety and Efficacy of Deep Wave Trabeculoplasty (DWT) in Primary Open Angle Glaucoma and Ocular Hypertension

Start date: November 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to investigate the safety and efficacy of bilateral DWT in subjects with POAG or OHT compared to active and sham controls. The secondary purpose of the study is to investigate the durability, repeatability, and does response of the same.

NCT ID: NCT02047630 Terminated - Ocular Hypertension Clinical Trials

Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension

Start date: January 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension. This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.

NCT ID: NCT02042703 Terminated - Clinical trials for Primary Open Angle Glaucoma

Imaging Lens Deposits in Exfoliation Syndrome

Start date: February 2014
Phase: N/A
Study type: Observational

The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has many ways of showing up in the eye, including the formation of deposits in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance of developing a type of glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the eye without requiring contact with the eye. We will compare lens images of subjects with exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts. This type of imaging could be used in patients with known diagnosis of exfoliation syndrome to track disease progression and see how they respond to possible treatments. We also hope that with this imaging technology we can detect early changes in currently unaffected eyes, which could be useful for predicting which patients may develop the disease.

NCT ID: NCT01983579 Terminated - Open Angle Glaucoma Clinical Trials

TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection

Start date: October 2013
Phase: Phase 4
Study type: Interventional

This is a prospective, open label study assessing the 24-hour IOP patterns using TF in patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related macular degeneration). The study will be proposed to patients with AMD and patients with AMD and concomitant open angle glaucoma (OAG). The study will be conducted in two stages. In both stages, patients will remain ambulatory and will be encouraged to follow a schedule as close to their usual lifestyle as possible, with the exception of particular activities such as caffeine intake, playing wind instruments, yoga and strenuous exercise. A patient diary will be distributed for the capture of patient activities during the TF pattern recording. Upon completion of each session, the CLS (contact lens sensor) will be removed and a final ophthalmic examination will be conducted. In the first stage of the study, 20 patients with neovascular AMD with an IOP in the normal range and no concomitant glaucoma will be recruited. After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. One eye will be selected for the study. If both eyes are eligible, the study eye will be selected in random manner. All 20 AMD patients will receive two 24-hour recording sessions (S) with the TF CLS, at monthly interval. In the first session (S1) anti-VEGF injection will be carried out according to the study center standard protocol. For the second 24-hour TF recording session (S2), patients will be randomly distributed into three groups. Group A, consisting of 5 patients, will receive anti-VEGF injection with a different anti-VEGF substance as compared to S1. Group B, also consisting of 5 patients, will receive anti-VEGF without sclerotomy occlusion after injection as compared to S1. Finally, group C, including 10 patients, will receive anti-VEGF in a different dose (injection volume) as compared to S1. The randomization ratio between groups A, B and C is 1:1:2. The overall study duration for an eligible patient in the first stage of this study is limited to 5 weeks. If in the first stage of this study an injection protocol is identified that provokes significantly lesser elevation on the TF pattern, the alternative injection protocol will be evaluated against the current standard protocol. For the second stage, 30 patients of whom 15 with neovascular AMD and 15 with neovascular AMD and concomitant OAG will be recruited. After giving informed consent and confirmation of eligibility, all patients will receive two 24-hour TF CLS recording sessions (S3 and S4) at monthly interval, during which anti-VEGF injection according to the standard and alternative protocol will be carried out in random sequence. The overall study duration for a patient in the second stage of the study is limited to 5 weeks. The study has been planned to recruit 20 eligible patients in the first stage within 12 weeks from the date of initiation. The second stage will recruit 30 patients within 16 weeks. Hence the overall study duration from the first patient accrued into the study until last patient out equates to about 33 weeks. Allowing for a database lock within 4 weeks of study completion, a preliminary statistical report on the primary efficacy endpoint is foreseen within 2 weeks thereafter.