An interventional study of drug delivery system and XALATAN® in Glaucoma, Ocular Hypertension and IOP, sponsored by Shaare Zedek Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-28.
Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Treatment
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Among 27 studies in Glaucoma with a site in Israel — 1 open to participants now, 1 under way, none of them phase 3. Glaucoma · Israel.
Among the 27 studies in Glaucoma with a site in Israel, this one is the 14th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2018, is one of 10 with no phase, and was the 26th registered.
1,419 studies on the registry are indexed under Glaucoma; 221 are open to participants now.
Browse Glaucoma studies →1 of the 27 studies in Glaucoma with a site in Israel is open now. Recruiting first, the newest first:
Sheba Medical Center · Sites in Israel
Ages 18–80 · Healthy volunteers
A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →
Of the 155 Glaucoma studies recruiting now, 113 (73%) set no upper age limit and 9 (6%) stop at 75 or younger; 13 take children under 18; 44 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 61 across 964 interventional studies indexed under Glaucoma.
Median enrollment 80 across the 17 interventional studies, 100 across the 9 observational. Of the 16 that completed or were terminated, 3 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 27 have an industry lead sponsor. The 10 most frequent:
Shaare Zedek Medical Center is the lead sponsor of 195 studies on the registry; 19 are open to participants now.
Shaare Zedek Medical Center has 2 studies filed under Glaucoma — fewer than ten, so there is no comparison to draw.
1 of the studies in Glaucoma with a site in Israel that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02014389Sheba Medical CenterEvaluation of Objective Perimetry Using Chromatic Multifocal Pupillometer | 2026-12-31 |
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Among the 27 studies in Glaucoma with a site in Israel, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Glaucoma is the most frequent cause of irreversible \& preventable blindness worldwide, affecting about 2% of the world's population in people over 40. The major risk factor, and only treatable factor in glaucoma, is increased intraocular pressure (IOP). IOP reduction can slow or arrest the progression of vision loss.
Current treatment consists of drops administered on a daily basis with unfortunately low patient compliance, increasing the chance of blindness.
Eximore's product aims to eliminate the need to apply eye drops on a daily basis and thus solves the significant problem of patient compliance.
Device Description - A combination of punctual plug (new product) as delivery system for Latanoprost (already approved drug). The plug has 2 different sizes of "big plug" (450 µg API) and "small plug" (250 µg API) (Neck diameter of 1.08 mm and 1.06 mm, accordingly) EXP-LP punctum plug is intended to be used as drug delivery system to improve patient compliance and outcomes. EXP-LP is a combination therapy non-invasive insert that replaces eye drops and provides sustained drug therapy for chronic eye problems such as glaucoma.
Xalatan (latanoprost) has been marketed for nearly 15 years, and its performance in reducing IOP is well established Study Design - This is a prospective, single center, open-label, controlled ("split body" design) non-randomized study performed in early visual field defects open angle glaucoma or ocular hypertension patients.
Study Population and Justification - 40 patients with open angle early visual field defects glaucoma (treated with eye drop medications) or ocular hypertension will be enrolled to the study. Due to early feasibility stage of the study, no formal sample size calculation was done for this study.
The intent to treat (ITT) population, defined as enrolled participants including those who leave the study prematurely during the screening period (before EXP-LP insertion).
Handling of Participant Withdrawals - Participants who leave the study prematurely during the screening period (before EXP-LP insertion) will not be replaced and will not be accounted for in the ITT study population. The discontinuing patient will be followed for safety by a phone call, one month after exiting the study. Each case of premature withdrawal will be properly recorded in the Screening Failure Log.
Patient Screening - Prior to any study-related procedure, delegated study team members will approach potentially eligible adult subjects diagnosed with early visual field defects open angle glaucoma or ocular hypertension. Those who may be eligible will be offered the choice of undergoing screening to be enrolled in the study or receiving standard public treatment for their current illness without participating in the study. Subjects who do not meet inclusion criteria or who are for any other reason determined to be too ill for inclusion in the study, or who decline to participate in the study, will be considered and recorded as "screen failure" and receive standard and appropriate treatment.
Informed Consent: The informed consent document will be signed and dated for screening and enrollment and each patient consenting will be documented in the patient medical binder. The patient will be given a copy of the consent form together with the study doctor's letter at the time of enrollment. The clinician will ask the patient about his plans and his willingness to attend all scheduled follow-up visits.
Each patient is considered as a Block unit and each of his eyes is considered the investigational unit. Patients will be identified by a serial number and will be numbered according to their serial recruitment (2 digits).
TRIAL PROCEDURES: All study visits will be performed at morning time (8 a.m. to 10 a.m.) in order to unify measurements and reduce intra-patient variations (across measurements). After informed consent is obtained, a case record form (CRF) including all aspects listed below will be recorded. Eligible patients will be enrolled into the study and will be monitored according to ophthalmic standard examinations.
Visit 1: Screening and pre-insertion washout, as part of pre-operative visit (2-4 weeks before grafting procedure - visit 2)
Following signing of informed consent, potential patients that their treated IOP is lower than 26 mmHg on at least 2 consecutive examinations will be screened for study enrolment by assessment of inclusion and exclusion criteria. The following assessments will be performed:
In case their IOP level is yet to be influenced by the washout (less than 3 mmHG increase), an additional visit (2b, 4 weeks after first screening visit) will be scheduled and performed with the patient. In case the patient IOP was increased by less than 3 mmHG in visit 2b, or either the patient IOP is >30 mmHg for glaucoma patients or >32 mmHg for ocular hypertension patients (exit criteria) that patient will discontinue the study and will be recorded as screening failure.
Once inclusion criteria #4 is verified (either 2a or 2b) study eligibility will be confirmed and the following assessments will be evaluated:
Prior to plug insertion prophylactic topical antibiotic (one eye-drop) will be given to the selected eye.
The plug will be inserted to the lower lacrimal punctum (tear duct) using routine curved eye forceps and under topical anesthesia with drops and using the physician biomicroscope.
Xalatan © administration - the second eye will receive mono-treatment of Xalatan © (Pfizer, latanoprost mono-treatment eye drops) as an internal control. According to the manufacturer's instructions for use - the recommended dosage is one drop once daily. Study administration will be in the evening time. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. Xalatan will be administered by the patient until end of the study, and mis-compliance will be documented in the CRF.
Short-term follow up visits:
Visit 3-8: clinical and biomicroscope examinations (see appropriate time windows below)
The following assessments will be performed during each visit at the hospital clinic:
Plug tolerability follow-up - During each visit, placement of plug will be verified. If the plug is not visualized or if the subject is inconvenienced by the inserted plug, the investigator can choose to insert another plug with a different size up to a maximum of 3 replacements.
Visit 8: Investigational EXP-LP plug removal (termination): (3 months (+\- 7 days) from plug insertion) In addition to the above mentioned study evaluations, EXP-LP plug will be removed by study qualified investigator under prior topical prophylactic antibiotic (one eye-drop) topical anaesthesia drops, using a biomicroscope and routine curved eye forceps. Intactness of the plug will be examined and recorded in the CRF
Un-scheduled visit:
The study investigator will instruct the patient to immediately contact the study team in case of: plug loss, intraocular inflammation, eyelid edema and keratitis.
The patient must call the study nurse to schedule an un-scheduled visit which may only be performed by one of the study investigators, and will be reported to the principal investigator.
For unscheduled visits the patient will be clinically managed by the study team with additional full eyes examination to be done at the discretion of the investigator.
Data Monitoring and Quality Control - The investigator, through an appointed Clinical Research Associate (CRA), will be responsible for implementing and maintaining quality assurance and quality control systems with written Standard Of Procedures to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s), including ISO 14155:2011.The investigator will be responsible for ensuring direct access to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the hospital, and inspection by Israeli regulatory authorities. Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. The study CRA will verify that (a) The rights and well-being of human patients are protected, (b) The reported trial data are accurate, complete, and verifiable from source documents and (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s) (including ISO 14155:2001). The monitor will submit a written report after each trial-site visit or trial related communication. A report should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted. A report should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance. To ensure compliance of this investigator initiated trial with current national regulations and the ICH guidelines, data generated by this study will be available for inspection upon request by representatives of the local health authorities- IRB or the national authorities - MOH, or any entity providing support for this trial. The general scope of such visits would be to inspect study data (regulatory requirements), source documentation and CRF completion in accordance with current GCP, the ICH guidelines and the respective local and national government regulations and guidelines.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EXP-LP is a novel and innovative drug delivery system aiming to improve patient compliance and outcomes. EXP-LP punctum plug, is a non-invasive insert that replaces eye drops and provides sustained therapy for glaucoma, dry eye and other major eye diseases. EXP-LP is a combination of an ophthalmic prostaglandin drug (Latanoprost). The prostaglandin drug works by increasing the natural outflow of fluid from inside the eye
Device: drug delivery system
XALATAN® (latanoprost ophthalmic solution) is an eye drop used to treat high eye pressure/intraocular pressure in people with open-angle glaucoma or ocular hypertension. XALATAN is administrated once a day
Drug: XALATAN®
The EXP-LP sustained released formula inserted into a small punctual plug. The plug is designed to release the drug over a period of up to 6 months in a slow release profile.
Also known as: punctum plug
one drop in the affected eye(s) once daily in the evening
Also known as: latanoprost ophthalmic solution
Safety Endpoint - the incidence of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0.
Main Adverse Event that will be focused on during the study: * Irritation and local discomfort * Increased Lacrimation * Increased mucus * Intraocular inflammation * Ocular redness * Eyelid Edema * Hyperaemia conjunctival erythema * Keratitis
Time frame: Will be evaluated through study completion (3 months)
Tolerability Endpoint - The incidence of subjects withdrew due to plug inconvenience and plug incompatibility
Tolerability will be evaluated on the basis of withdrawal rates over time.
Time frame: Will be evaluated through study completion (3 months)
Exploratory Endpoint - (preliminary efficacy): To demonstrate the performance in lowering IOP of EXP-LP in comparison to Xalatan © eye drops treatment in the second eye.
Endpoints will be IOP differences from baseline of: i. The plug inserted eye compared to the controlled treated eye at all study follow-up visits ii. The plug inserted eye at all study follow-up visits
Time frame: Will be evaluated through study completion (3 months)
Plan to share: No — IPD is not intended to be shared as this will be a single site study. The study will be public at ClinicalTrial.gov
Start is estimated for Jun 2018; primary completion for Jun 2019, 12 months later.
Of 230 non-industry interventional studies with no phase under Glaucoma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's planned 12 months is below that.
Counting every sponsor, half of 288 studies reached it within 30 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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