Clinical Research Directory

Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

The objectives of this study are: * To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT). * To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle. * To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.

This Follow-up Extension Study is Aimed to Monitor the Long-term IOP-lowering Performance/Efficacy and Safety of the MINT® Procedure in Open Angle Glaucoma Eyes.

This follow-up extension study is planned to invite all patients who underwent the MINT® surgery and completed Month 24 Visit in the prior MMS EEU-7 study. It is assumed that approximately 20 patients/eyes, achieved qualified success of ≥20% IOP reduction from baseline without reoperation for glaucoma and with same or less medications in the prior MMS EEU-7 study, will be available for assessment in this study. The data from these patients will be included in the IOP performance and medication use analysis. In addition to these subjects, data from subjects defined as failure in the prior investigations with MINT® (see: STUDY ID: MMS EEU-4; STUDY ID: MMS EEU-7) will be included in the overall success analysis (i.e., Kaplan Mayer survival analysis). Based on recommendations of the EGS expert discussion group (European Glaucoma Society (EGS), 2023), the IOP levels of 2-3 mmHg and 20%-30% medication free patients have been proposed as the minimal clinically important difference (MCID) for surgical interventions for glaucoma. In this study, by 3 years post MINT® surgery, a sample size of 20 patients is expected to be adequate to demonstrate a reduction of at least -6 mmHg with 95% confidence interval (CI) lower limit of at least -4.6 mmHg which is higher than the MCID required; and at least 45% of free-medication patients with 95%CI lower limit of 21.8% which is in line with the minimum MCID recommendations.

Changes in Intraocular Pressure After Intravitreal Injection

Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections introduce additional fluid volume into the eye, which can cause an acute, transient elevation in intraocular pressure (IOP). The purpose of this prospective observational study is to evaluate the immediate and early changes in intraocular pressure following intravitreal anti-VEGF injections and to determine how rapidly pressure recovers toward baseline levels. Adult participants scheduled to receive routine intravitreal anti-VEGF therapy for established clinical indications, such as diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion, will be enrolled. Intraocular pressure will be measured using an Icare rebound tonometer with single-use disposable probes before injection (baseline) and at 1 minute, 5 minutes, and 20 minutes post-injection. The study will also analyze whether factors such as refractive error, the number of prior injections, or the type of anti-VEGF drug administered affect the severity of post-injection pressure spikes and subsequent recovery.

A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population

The objective of this study is to evaluate the safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese participants with Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT), or Normal Tension Glaucoma (NTG).

Selective, Micropulse and Pattern Laser Trabeculoplasty in Medically Treated Open-angle Glaucoma.

This randomized, single-centre, three-arm trial compared three subvisible laser trabeculoplasty delivery protocols in eyes with open-angle glaucoma already receiving intraocular pressure (IOP)-lowering medication: selective laser trabeculoplasty (SLT, 3-nanosecond pulses), micropulse laser trabeculoplasty (MLT, 577 nm with 15% duty cycle), and pattern laser trabeculoplasty (PLT, 5-ms pattern delivery). Ninety eyes of 90 patients were allocated 1:1:1 to a single 360-degree session and followed for 6 months. The primary outcome was IOP at 6 months, with an equivalence margin of +/-2.0 mmHg prespecified for pairwise comparisons. Secondary outcomes were percentage IOP change, number of IOP-lowering medications, cumulative treatment success (IOP reduction of at least 20% from baseline without an increase in medications), and adverse events. Outcome assessment was performed by a second ophthalmologist masked to allocation and to clinical history.

Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery

The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery. The study is conducted in two stages. The first stage (Stage 1/Phase 1) is intended to study the safety of 3 different doses of the study medication (called TimoD implant). The second stage (Stage 2/Phase 2) of the study is intended to study in greater detail the efficacy and safety of the 3 doses of the TimoD implant in comparison to a standard approved medication, timolol eye drops for 3 years.

Optimal Treatment Protocol for Selective Laser Trabeculoplasty

A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.

Prophylactic Use of Timolol Maleate to Prevent Intraocular Pressure Elevation After Nd:YAG Laser Posterior Capsulotomy

This randomized controlled trial evaluated whether a single drop of 0.5% timolol maleate, administered before neodymium-doped yttrium aluminium garnet (Nd:YAG) laser posterior capsulotomy, reduced the rise in intraocular pressure compared with standard care alone. The study included adults aged 18-65 years who had developed posterior capsular opacification at least 3 months after cataract surgery and were scheduled to undergo Nd:YAG laser posterior capsulotomy. Participants were randomly assigned to receive either prophylactic topical timolol maleate or standard care without prophylactic timolol. Intraocular pressure was measured before the laser procedure and again 1 hour after the procedure by an ophthalmologist who was unaware of the assigned treatment. The study was based on the hypothesis that mean intraocular pressure 1 hour after posterior capsulotomy would be lower among participants who received prophylactic timolol maleate than among those who received standard care alone.

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension

The goal of this clinical trial is to determine the dose of PA5108 Ocular Implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.

Dorzolamide/Brimonidine/Timolol Impact on Ocular Surface, Glaucoma Progression & Chatbot Follow-up: GLAUCO-TECH

The primary objective of this study is to evaluate the ocular surface safety of an ophthalmic solution indicated for the management of glaucoma, containing the active ingredients dorzolamide, timolol, and brimonidine, in patients diagnosed with primary open-angle glaucoma. The most relevant questions to be answered by this study are: In patients with ocular hypertension or open-angle glaucoma, does treatment with the preservative-free dorzolamide-timolol-brimonidine combination improve ocular surface health? Will there be differences in treatment adherence between patients with ocular hypertension or open-angle glaucoma using a preservative-free dorzolamide-timolol-brimonidine combination versus a combination with preservatives? Will there be differences in therapeutic efficacy between patients with ocular hypertension or open-angle glaucoma when using a preservative-free dorzolamide-timolol-brimonidine combination versus a preservative-containing dorzolamide-timolol-brimonidine combination? Will there be differences in changes in biomolecular markers on the ocular surface between patients with ocular hypertension or open-angle glaucoma when using a preservative-free dorzolamide-timolol-brimonidine combination versus a preservative-containing dorzolamide-timolol-brimonidine combination? Researchers will study these differences by comparing a formulation with the dorzolamide, timolol, and brimonidine combination that uses a preservative versus another with the same combination that does not use preservatives. Preservatives are used in ophthalmic solutions to prevent bacterial contamination. New technological developments in bottles allow for solutions without the need for preservatives. Participants must: * Take their medication according to the investigator's instructions for at least 4 months * Attend follow-up appointments at the beginning, and every 2 months until 4 months have passed * Answer phone calls every 15 days * Complete the quality of life questionnaires within the timeframes defined by the investigator

Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects

The goal of this clinical trial is to compare participants treated with latanoprost to those treated with Rocklatan (netarsudil/latanoprost) to determine whether the addition of netarsudil results in greater improvements in episcleral venous blood flow in adults with glaucoma or ocular hypertension. Episcleral venous blood flow will be measured using erythrocyte-mediated angiography (EMA) and laser speckle contrast imaging (LSCI). The main questions this study aims to answer are: * Does Rocklatan produce greater increases in episcleral venous blood flow than latanoprost alone? * Can EMA and LSCI reliably detect changes in episcleral venous blood flow following treatment with these medications? Participants will: * Be randomized to receive either latanoprost or Rocklatan * Undergo imaging of the episcleral veins using EMA and LSCI before, during, and after treatment, and * Complete study visits that include standard ophthalmic examinations and intraocular pressure measurements. Hypothesis: The investigators hypothesize that latanoprost, which primarily increases uveoscleral outflow, will not significantly affect the distal episcleral circulation. In contrast, Rocklatan, through its netarsudil component, is expected to produce measurable increases in episcleral venous flow.

[KJ-TFC-005] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

\[KJ-TFC-005\] Phase 3 Study, Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension

The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is: Does the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension? Researchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)). Participants will: * Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated. * Complete a baseline visit to further evaluate eligibility in the study eye. * Undergo surgery to implant the BIM-DRS (BIM-DRS and SpyGlass IOL for Cohorts 3 and 4). Only one eye of each participant will be treated. * Complete post-operative follow-up visits for evaluation at Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 (last study visit).

Imaging the Effects of Netarsudil (Rhopressa) on the Trabecular Meshwork in Glaucoma and Ocular Hypertension

This study evaluates the effects of netarsudil (Rhopressa) on the trabecular meshwork in subjects with ocular hypertension or open-angle glaucoma. Participants will be randomized to receive either netarsudil or placebo (artificial tears). High-resolution imaging using adaptive optics gonioscopy, anterior segment optical coherence tomography (AS-OCT), and OCT gonioscopy will be performed at baseline and after approximately 14 days of treatment. The primary objective is to assess changes in trabecular meshwork lamellae spacing, with secondary measures including trabecular meshwork height, width, and Schlemm's canal diameter.

MINIject Global Long-Term Follow-up Study

The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Efficacy and Safety of DNN.31.19.026 for Ocular Hypertension or Primary Open-Angle Glaucoma

This study aims to evaluate the safety and efficacy of DNN.31.19.026 compared with Cosopt® for the treatment of ocular hypertension or primary open-angle glaucoma.

SD-OCT Multimodal Analysis in GLaucoma

Glaucoma is the first cause of irreversible blindness worldwide with more than 60 millions people affected in 2010. It is defined as a neurodegenerative disease characterized by a progressive loss of retinal ganglion cells (RGC), visual field deterioration and optic nerve excavation. Intraocular pressure (IOP) is the most common risk factor. Despite its severity, its impact on quality of life and an existing treatment that can delay visual field damages, there is no recommended strategy to screen the disease. Clinical evaluation of optic nerve head excavation performed either by ophthalmologists or glaucoma specialists is highly inter-observer dependent and limits its accuracy to diagnose glaucoma. Additionally, up to 30 to 40% of nerve fiber layer may be lost before detecting first visual field defects, thus making this tool not accurate enough for screening purposes. Spectral-Domain Optical coherence tomography (SD-OCT) imaging technology allows precise and reproducible measurements of optic nerve head structures and retinal layers mainly related to the speed of acquisition and an axial resolution of 5 microns. New SD-OCT parameters have been developed to improve its diagnostic accuracy for glaucoma disease. The investigators therefore investigate performances of SD-OCT to discriminate glaucoma patients and controls. All subjects will undergo SD-OCT imaging (Spectralis™ OCT, Version 6.3, Heidelberg Engineering, Germany) and other study procedures in one single visit. All examinations performed on the subjects are non-significant risk.

AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension

A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China

This is a Phase III Study that includes a single arm, open-label, multi-dose PK study cohort and a randomized, evaluator-masked, active drug-control multicenter study. Subjects diagnosed with POAG (Primary Open Angle Glaucoma) or OHT (Ocular Hypertension) who meet eligibility criteria will washout of their current IOP lowering medication(s), if any. The study will investigate plasma pharmacokinetics of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension. It will investigate the safety of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension. There will be a bridging cohort and extension follow-up phase

Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension.

Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle glaucoma or ocular hypertension during 90 days

24-hour Effect of Rocklatan Compared With Latanoprost in Open Angle Glaucoma and Ocular Hypertension Patients

The purpose of this study is to evaluate the effect on 24-hour IOP reduction of netarsudil-latanoprost fixed combination in one eye compared to latanoprost alone in the contralateral eye, dosed daily, 1 drop at night (QD, PM) in adult subjects, at least 18 years of age, with open angle glaucoma (OAG) or ocular hypertension (OHT).

Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry

While elevated intraocular pressure (IOP) is no longer part of the definition of glaucoma it remains the sole proven modifiable risk factor for the onset and progression of glaucoma. IOP is known to vary with the time of day as well as with daily activities. The importance of the nycthemeral IOP pattern for successful management of glaucoma has been well documented, especially for patients who experience visual loss despite apparently normal and/or controlled IOP during office hours. The current way of assessing nycthemeral IOP fluctuation is to perform repeated discrete tonometry measurements, once per hour in the best cases. Since its development in the 50s, Goldmann applanation tonometry (GAT) has remained the gold standard method for measuring IOP, despite its limitations. However, tonometry may be an imperfect method for measuring changes in IOP because it allows only snapshot and non-continuous measurements, it is not physiologic and disturbs the sleep architecture. There have been many efforts in the past decades to search for an ambulatory and frequent method to monitor IOP for 24 hours. In this context, Sensimed AG has recently developed a sensing contact lens-based device intended to measure IOP over 24 hours, the Goldfish (GF). First-in-man data obtained with this device showed agreements between IOP measured by GF and values obtained by standard tonometry in the same eye, comparable to literature results for routinely used tonometry devices. However, this pilot study included 9 subjects only with improvable safety, tolerability and efficacy profiles. The main goal of this study is to assess IOP measurements with the GF and compare the values with those obtained by standard tonometry in patients with open angle glaucoma (OAG) and ocular hypertension (OHT).