Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug -EXP-LP
EXP-LP
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2017
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedNovember 28, 2017
September 1, 2017
1 year
October 2, 2017
November 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Will be evaluated through study completion (3 months)
Secondary Outcomes (1)
Tolerability Endpoint - The incidence of subjects withdrew due to plug inconvenience and plug incompatibility
Will be evaluated through study completion (3 months)
Other Outcomes (1)
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.
Will be evaluated through study completion (3 months)
Study Arms (2)
EXP-LP punctum plug
EXPERIMENTALEXP-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
XALATAN®
ACTIVE COMPARATORXALATAN® (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
Interventions
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.
one drop in the affected eye(s) once daily in the evening
Eligibility Criteria
You may qualify if:
- years consecutive males or females diagnosed with open angle early visual field defects glaucoma or ocular hypertension in both eyes and treated with eye drop medications .
- Treated IOP lower than 26 mmHg on at least 2 consecutive examinations.
- If glaucoma, mean deviation must be better than -10 mmHg in study eye (early visual field defects glaucoma)
- IOP increase of at least 3 mmHg from start of washout in both eyes.
You may not qualify if:
- Any record of IOP ever being higher than 33 mmHg.
- Corneal or other anatomical abnormalities preventing reliable applanation tonometry
- Severe dry eye,
- Use of contact lenses
- Intolerance or contraindication to latanoprost or BAK
- Indication of optic nerve damage and visual function deterioration according to the investigator's judgment
- Lower lacrimal Punctum (tear duct) diameter is smaller than 0.4mm or greater than or equal to 0.75mm
- Pregnancy or lactation (questioned by the consenting investigator), unwillingness to avoid pregnancy
- Use of (topical or systemic) corticosteroids within 2 months before enrolment. Any systemic condition or medication that can affect IOP.
- Known intolerance to PGA eye drops
- Use of oral IOP-lowering medication
- Punctual occlusions or other anatomic abnormality
- Previous incisional ocular surgery (e.g., conventional filtering surgery) to lower IOP
- Evidence of current or prior angle closure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Related Publications (7)
Boland MV, Ervin AM, Friedman DS, Jampel HD, Hawkins BS, Vollenweider D, Chelladurai Y, Ward D, Suarez-Cuervo C, Robinson KA. Comparative effectiveness of treatments for open-angle glaucoma: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 Feb 19;158(4):271-9. doi: 10.7326/0003-4819-158-4-201302190-00008.
PMID: 23420235RESULTBurr J, Azuara-Blanco A, Avenell A, Tuulonen A. Medical versus surgical interventions for open angle glaucoma. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD004399. doi: 10.1002/14651858.CD004399.pub3.
PMID: 22972069RESULTChen R, Yang K, Zheng Z, Ong ML, Wang NL, Zhan SY. Meta-analysis of the Efficacy and Safety of Latanoprost Monotherapy in Patients With Angle-closure Glaucoma. J Glaucoma. 2016 Mar;25(3):e134-44. doi: 10.1097/IJG.0000000000000158.
PMID: 25383466RESULTCucherat M, Stalmans I, Rouland JF. Relative efficacy and safety of preservative-free latanoprost (T2345) for the treatment of open-angle glaucoma and ocular hypertension: an adjusted Indirect comparison meta-analysis of randomized clinical trials. J Glaucoma. 2014 Jan;23(1):e69-75. doi: 10.1097/IJG.0b013e3182a075e6.
PMID: 23881267RESULTEveleth D, Starita C, Tressler C. A 4-week, dose-ranging study comparing the efficacy, safety and tolerability of latanoprost 75, 100 and 125 mug/mL to latanoprost 50 mug/mL (xalatan) in the treatment of primary open-angle glaucoma and ocular hypertension. BMC Ophthalmol. 2012 May 18;12:9. doi: 10.1186/1471-2415-12-9.
PMID: 22607109RESULTGarway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, Bourne RR, Broadway DC, Cunliffe IA, Diamond JP, Fraser SG, Ho TA, Martin KR, McNaught AI, Negi A, Patel K, Russell RA, Shah A, Spry PG, Suzuki K, White ET, Wormald RP, Xing W, Zeyen TG. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Lancet. 2015 Apr 4;385(9975):1295-304. doi: 10.1016/S0140-6736(14)62111-5. Epub 2014 Dec 19.
PMID: 25533656RESULTKompella UB, Kadam RS, Lee VH. Recent advances in ophthalmic drug delivery. Ther Deliv. 2010 Sep;1(3):435-56. doi: 10.4155/TDE.10.40.
PMID: 21399724RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tal Lavi
Gsap Medical Ltd.
- STUDY CHAIR
Ishay Attar, CEO
Eximore Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2017
First Posted
October 23, 2017
Study Start
June 1, 2018
Primary Completion
June 1, 2019
Study Completion
September 1, 2019
Last Updated
November 28, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share
IPD is not intended to be shared as this will be a single site study. The study will be public at ClinicalTrial.gov