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Ocular Hypertension clinical trials

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NCT ID: NCT02623023 Withdrawn - Ocular Hypertension Clinical Trials

Prophylaxis for Anti-VEGF-induced IOP Elevation

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The purpose of our study is to determine the effect of prophylactic treatment with brimonidine/timolol fixed combination (Combigan®, Allergan; Dublin, IRL) or placebo therapy (Refresh tears®, Allergan; Dublin, IRL) on long-term IOP measurements in patients receiving serial intravitreal injection of 0.5 mg ranibizumab (0.05 mL) with six months follow-up. Intraocular pressure measurements will be correlated with changes on ancillary testing (Humphrey 24-2 visual field testing and optical coherence tomography (OCT) of the optic nerve head (ONH). Our study would be the first large, prospective, randomized double-blind placebo-controlled trial to examine the relationship between anti-vascular endothelial growth factor (VEGF) therapy and sustained ocular hypertension.

NCT ID: NCT02622334 Completed - Glaucoma Clinical Trials

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Start date: December 29, 2015
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151 following 7 days of topical ocular treatment in patients with primary open angle glaucoma or ocular hypertension.

NCT ID: NCT02617459 Completed - Ocular Hypertension Clinical Trials

Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension

Start date: January 4, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.

NCT ID: NCT02585375 Recruiting - Glaucoma Clinical Trials

Latanoprost Preserved Versus Unpreserved: Effect on Tear Film Thickness as Measured With OCT

Start date: September 17, 2015
Phase: Phase 4
Study type: Interventional

Topical antihypertensive eye drops are a key element of modern antiglaucoma treatment. Most of these eye drops contain preservatives to allow for the use of multi-dose containers. In the recent years evidence has, however, accumulated that these preservatives may induce ocular surface disease (OSD). This is particularly true for the most widely used preservative, benzalkonium chloride (BAK). Whereas this is well documented in many in vitro and animal studies, evidence from clinical trials is sparse. The only randomized masked study that showed superiority is a pivotal company-sponsored study indicating improved tolerability and reduced hyperemia of unpreserved versus preserved latanoprost eye drops. The investigators have recently introduced an optical coherence tomography (OCT) technology that provides a resolution as high as 1.2 µm for the human cornea. Using this technology the investigators were able to show that tear film thickness (TFT) is negatively correlated with symptoms of OSD. Changes in TFT can be assessed with very high sensitivity below the level of resolution as also evident from studies after administration of lubricants. In the present study, the investigators hypothesize that switching glaucoma patients from preserved prostaglandin analogues to unpreserved latanoprost is associated with an increase in TFT as measured with OCT. As a control the investigators will use preserved latanoprost and the study hypothesis will be tested in a randomized, controlled, single-masked parallel group design. TFT is chosen as main outcome variable, standard measures for signs and symptoms of OSD are selected as secondary outcomes. The present study may provide valuable information on the superiority of unpreserved versus preserved therapy.

NCT ID: NCT02571712 Completed - Ocular Hypertension Clinical Trials

Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension

Start date: November 10, 2015
Phase: Phase 4
Study type: Interventional

A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blocker or prostaglandin analogues.

NCT ID: NCT02565173 Completed - Clinical trials for Ocular Hypertension (OHT)

Study of Trabodenoson in Adults With Ocular Hypertension or Primary Open-angle Glaucoma

MATrX-1
Start date: September 2015
Phase: Phase 3
Study type: Interventional

Phase III trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with Ocular Hypertension or Primary Open-Angle Glaucoma. All subjects who meet the study's enrollment criteria following Screening will undergo washout of all prohibited medications, including their routine glaucoma medications. During the Placebo Run-In Period, placebo is administered twice daily to both eyes in all subjects. During the Treatment Period, study drug is applied to both eyes for a total of 12 weeks followed by an Observation Period of approximately 7 days wherein no study eye drops are instilled. The purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% QD or 4.5% BID for 12 weeks. Timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.

NCT ID: NCT02558400 Completed - Ocular Hypertension Clinical Trials

Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Start date: September 18, 2015
Phase: Phase 3
Study type: Interventional

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution. Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.

NCT ID: NCT02558374 Completed - Ocular Hypertension Clinical Trials

Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

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

To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

NCT ID: NCT02537015 Completed - Ocular Hypertension Clinical Trials

An Open-label Extension Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert

OLE2
Start date: August 10, 2015
Phase: Phase 2
Study type: Interventional

This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).

NCT ID: NCT02531152 Completed - Clinical trials for Open Angle Glaucoma -Ocular Hypertension

28-Day Repeated Topical Study to Evaluate the Safety and Activity of 5 Escalating Dose Levels of SAR366234 and One Dose of Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension

Start date: September 2015
Phase: Phase 1
Study type: Interventional

Primary Objective: To assess the local and systemic safety and tolerability of ascending repeated topical doses of SAR366234 monotherapy in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) as compared to latanoprost. Secondary Objective: To assess the pharmacodynamic activity of ascending repeated topical doses of SAR366234 in patients with OAG or OHT as compared to latanoprost.