A Phase 2 Single-Masked, Randomized Study of Latanoprost PPDS in Ocular Hypertension or Open-Angle Glaucoma

NCT02014142 | Completed Phase 2

• 1 other identifier: PPL GLAU M1
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 18

Brief Summary

Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS placement on efficacy will also be examined.

Conditions

Ocular Hypertension; Open-Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• IOP change from baseline and the primary analysis time point will be the IOP assessment at Week 12

  12 weeks

Study Arms (2)

Group A. L-PPDS single occlusion

EXPERIMENTAL

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)

Group B. L-PPDS double occlusion

EXPERIMENTAL

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)

Interventions

Latanoprost Punctal Plug Delivery System (L-PPDS) DRUG

Latanoprost Punctal Plug Delivery System (L-PPDS)

Group A. L-PPDS single occlusion; Group B. L-PPDS double occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years or older at the time of the screening examination
• Subject diagnosed with bilateral OAG or OH
• 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
• Subject who has lower and upper puncta \> 0.5 mm and \< 0.9 mm (pre-dilation) in both eyes
• Subject must be able and willing to read, comprehend and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent
• 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
• 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
• Subject has a central corneal thickness of \> 500 μm and \< 600 μm in study eye
• Subject has a BCVA or pinhole visual acuity (Snellen) of 20/100 or better in both eyes

You may not qualify if:

• Subject with a history of non-response to topical prostaglandin eye drops for OAG/OH
• Subject with angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
• 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
• Subject with a history of intolerance to topical beta-blocker therapy
• Subject with \> 0.8 vertical cup or completely notched optic nerve head rim in either eye
• Subject with any functionally significant visual field loss or progressive field loss within the last year in either eye
• 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
• Subject with structural lid abnormalities (i.e., ectropion, entropion) in study eye
• Subject with an active lid disease in either eye (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment
• Subject with a history of chronic/recurrent inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye
• 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
• 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
• Subject with a history of penetrating keratoplasty in study eye
• Subject who is incapable of instilling ocular drops into his or her eyes
• Subject requiring the use of a contact lens in either eye at any time during the study period

Sponsors & Collaborators

• Mati Therapeutics Inc.: lead

Study Sites (18)

Arizona Eye Center

Chandler, Arizona, 85225, United States

Location

Arizona Glaucoma Specialists

Phoenix, Arizona, 85050, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Argus Research at Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Eye Associates of Fort Myers

Fort Myers, Florida, 33901, United States

Location

Indiana Universtiy - Eugene and Marilyn Glick Eye Institute Ophthalmology Center

Indianapolis, Indiana, 46202, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Great Lakes Eye Care

Saint Joseph, Michigan, 49085, United States

Location

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Comprehensive Eye Care, Ltd.

Washington, Missouri, 63090, United States

Location

Abrams Eye Institute

Las Vegas, Nevada, 89148, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Dr. Steven T. Simmons

Slingerlands, New York, 12159, United States

Location

Philadelphia Eye Associates

Philadelphia, Pennsylvania, 19148, United States

Location

Wills Eye Hospital

Phildelphia, Pennsylvania, 19107, United States

Location

University Eye Surgeons

Maryville, Tennessee, 37803, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (18)