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

Sponsor

Mati Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02014142

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Single-Masked, Randomized Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Subject with advanced diabetic retinopathy, branch retinal vein occlusion or central retinal vein occlusion in either eye
Subject with a history of macular edema in either eye
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)
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)
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)
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

Locations

	Site	City	State	Country	Postal Code
1	Arizona Eye Center	Chandler	Arizona	United States	85225
2	Arizona Glaucoma Specialists	Phoenix	Arizona	United States	85050
3	Wolstan & Goldberg Eye Associates	Torrance	California	United States	90505
4	Argus Research at Cape Coral Eye Center	Cape Coral	Florida	United States	33904
5	Eye Associates of Fort Myers	Fort Myers	Florida	United States	33901
6	Indiana Universtiy - Eugene and Marilyn Glick Eye Institute Ophthalmology Center	Indianapolis	Indiana	United States	46202
7	Cincinnati Eye Institute	Edgewood	Kentucky	United States	41017
8	Great Lakes Eye Care	St. Joseph	Michigan	United States	49085
9	Chu Vision Institute	Bloomington	Minnesota	United States	55420
10	Ophthalmology Associates	St. Louis	Missouri	United States	63131
11	Comprehensive Eye Care, Ltd.	Washington	Missouri	United States	63090
12	Abrams Eye Institute	Las Vegas	Nevada	United States	89148
13	Ophthalmic Consultants of Long Island	Lynbrook	New York	United States	11563
14	Dr. Steven T. Simmons	Slingerlands	New York	United States	12159
15	Philadelphia Eye Associates	Philadelphia	Pennsylvania	United States	19148
16	Wills Eye Hospital	Phildelphia	Pennsylvania	United States	19107
17	University Eye Surgeons	Maryville	Tennessee	United States	37803
18	Total Eye Care	Memphis	Tennessee	United States	38119