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Comparison of Latanoprost PPDS With Timolol Maleate GFS in Subjects With Ocular Hypertension or Open-Angle Glaucoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT02014142
First received: December 12, 2013
Last updated: September 29, 2016
Last verified: September 2016
  Purpose
Compare efficacy of the latanoprost punctal plug to timolol maleate ophthalmic gel forming solution (GFS) 0.5% (administered once every morning). Effect of configuration of L-PPDS placement on efficacy will also be examined.

Condition Intervention Phase
Ocular Hypertension
Open-Angle Glaucoma
Drug: Latanoprost Punctal Plug Delivery System (L-PPDS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Single-Masked, Randomized, Parallel Comparison of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Timolol Maleate Ophthalmic Gel Forming Solution 0.5% in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Mati Therapeutics Inc.:

Primary Outcome Measures:
  • IOP change from baseline and the primary analysis time point will be the IOP assessment at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A. L-PPDS single occlusion
Latanoprost Punctal Plug Delivery System (L-PPDS) continuous single occlusion; L-PPDS will be inserted in the lower punctum and no plug will be inserted in the upper punctum of each eye; L-PPDS will remain for a period of 14 weeks.
Drug: Latanoprost Punctal Plug Delivery System (L-PPDS)
Latanoprost Punctal Plug Delivery System (L-PPDS)
Experimental: Group B. L-PPDS double occlusion
Latanoprost Punctal Plug Delivery System (L-PPDS) continuous double occlusion; L-PPDS will be inserted in the lower punctum and non-therapeutic (NT) plug will be inserted in the upper punctum of each eye and both will remain for a period of 14 weeks.
Drug: Latanoprost Punctal Plug Delivery System (L-PPDS)
Latanoprost Punctal Plug Delivery System (L-PPDS)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years or older at the time of the screening examination
  2. Subject diagnosed with bilateral OAG or OH
  3. Subject IOP is currently controlled (< 21 mmHg) with a topical prostaglandin or in conjunction with one other topical ocular hypotensive drug, not including any fixed-combination formulations (i.e., Cosopt, Combigan, Azarga, etc.) for at least one month or more
  4. Subject who has lower and upper puncta > 0.5 mm and < 0.9 mm (pre-dilation) in both eyes
  5. Subject must be able and willing to read, comprehend and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent
  6. Subject must be willing to comply with study instructions, dosing (if applicable), agree to make all office appointments, and complete the entire course of the study
  7. Women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control, including intrauterine device (IUD); oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; or barrier methods with spermicide
  8. Subject has a central corneal thickness of > 500 μm and < 600 μm in study eye
  9. Subject has a BCVA or pinhole visual acuity (Snellen) of 20/100 or better in both eyes

Exclusion Criteria:

  1. Subject with a history of non-response to topical prostaglandin eye drops for OAG/OH
  2. Subject with angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
  3. Subject with a known sensitivity to latanoprost, timolol, fluorescein, topical anesthetic, silicone, any inactive ingredient of the L-PPDS or any other products required for the study procedures
  4. Subject with a history of intolerance to topical beta-blocker therapy
  5. Subject with > 0.8 vertical cup or completely notched optic nerve head rim in either eye
  6. Subject with any functionally significant visual field loss or progressive field loss within the last year in either eye
  7. Subject with a history of complications, AEs, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in study eye
  8. Subject with structural lid abnormalities (i.e., ectropion, entropion) in study eye
  9. Subject with an active lid disease in either eye (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment
  10. Subject with a history of chronic/recurrent inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye
  11. Subject who would require the use of any ocular topical medication(s), an over-the counter drop(s), ointment(s) or gel(s), other than the study ocular hypotensive medication(s) in either eye during the study period
  12. Subject who has had any ophthalmic surgical procedures (i.e., glaucoma laser, minimally invasive glaucoma surgery, cataract, refractive, etc.) in study eye within the last six months or will require ophthalmic surgery before completing the study
  13. Subject with a history of penetrating keratoplasty in study eye
  14. Subject who is incapable of instilling ocular drops into his or her eyes
  15. Subject requiring the use of a contact lens in either eye at any time during the study period
  16. Subject with advanced diabetic retinopathy, branch retinal vein occlusion or central retinal vein occlusion in either eye
  17. Subject with a history of macular edema in either eye
  18. Subject currently on any systemic medication [i.e., beta-blocker, carbonic anhydrase inhibitors, corticosteroids (including dermal), etc.], that may have an effect on the subject's IOP, or who will require its use during the study period (Note: an inhaled steroid, systemic beta-blocker or β-adrenoceptor antagonist may be permitted, providing the subject has maintained a stable dosage regimen for at least the last three months)
  19. Subject contraindicated to therapy with a beta-blocker (i.e., history or presence of bradycardia, untreated congestive heart failure, untreated second- or third-degree heart block, sino-atrial block, myasthenia gravis, cardiogenic shock, history or presence of bronchial asthma, bronchial hyperreactivity, severe chronic obstructive pulmonary disease, or history of bronchospasm)
  20. Subject with an uncontrolled systemic disease or a medical condition that may increase the risk associated with study participation or administration of study treatment or that may interfere with the interpretation of study results (e.g., autoimmune disease if the subject is on chronic medications and has ocular involvement; host-versus-graft disease)
  21. Subject currently participating or has participated within the last 30 days prior to the start of this study in a drug, device or other investigational research study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014142

Locations
United States, Arizona
Arizona Eye Center
Chandler, Arizona, United States, 85225
Arizona Glaucoma Specialists
Phoenix, Arizona, United States, 85050
United States, California
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
United States, Florida
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, United States, 33904
Eye Associates of Fort Myers
Fort Myers, Florida, United States, 33901
United States, Indiana
Indiana Universtiy - Eugene and Marilyn Glick Eye Institute Ophthalmology Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
United States, Michigan
Great Lakes Eye Care
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Chu Vision Institute
Bloomington, Minnesota, United States, 55420
United States, Missouri
Ophthalmology Associates
St. Louis, Missouri, United States, 63131
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States, 63090
United States, Nevada
Abrams Eye Institute
Las Vegas, Nevada, United States, 89148
United States, New York
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
Dr. Steven T. Simmons
Slingerlands, New York, United States, 12159
United States, Pennsylvania
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States, 19148
Wills Eye Hospital
Phildelphia, Pennsylvania, United States, 19107
United States, Tennessee
University Eye Surgeons
Maryville, Tennessee, United States, 37803
Total Eye Care
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Mati Therapeutics Inc.
  More Information

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02014142     History of Changes
Other Study ID Numbers: PPL GLAU M1 
Study First Received: December 12, 2013
Last Updated: September 29, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Glaucoma
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Maleic acid
Latanoprost
Timolol
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on September 30, 2016