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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014142
• Other study ID #: PPL GLAU M1
• Status: Completed
• Phase: Phase 2
• First received: December 12, 2013
• Last updated: January 16, 2017
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Mati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Latanoprost Punctal Plug Delivery System (L-PPDS)
Latanoprost Punctal Plug Delivery System (L-PPDS)

Locations

Country	Name	City	State
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Argus Research at Cape Coral Eye Center	Cape Coral	Florida
United States	Arizona Eye Center	Chandler	Arizona
United States	Cincinnati Eye Institute	Edgewood	Kentucky
United States	Eye Associates of Fort Myers	Fort Myers	Florida
United States	Indiana Universtiy - Eugene and Marilyn Glick Eye Institute Ophthalmology Center	Indianapolis	Indiana
United States	Abrams Eye Institute	Las Vegas	Nevada
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	University Eye Surgeons	Maryville	Tennessee
United States	Total Eye Care	Memphis	Tennessee
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania
United States	Wills Eye Hospital	Phildelphia	Pennsylvania
United States	Arizona Glaucoma Specialists	Phoenix	Arizona
United States	Dr. Steven T. Simmons	Slingerlands	New York
United States	Great Lakes Eye Care	St. Joseph	Michigan
United States	Ophthalmology Associates	St. Louis	Missouri
United States	Wolstan & Goldberg Eye Associates	Torrance	California
United States	Comprehensive Eye Care, Ltd.	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP change from baseline and the primary analysis time point will be the IOP assessment at Week 12		12 weeks