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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Mati Therapeutics Inc.
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT02014142
First received: December 12, 2013
Last updated: September 25, 2014
Last verified: September 2014

December 12, 2013
September 25, 2014
December 2013
December 2014   (final data collection date for primary outcome measure)
IOP change from baseline and the primary analysis time point will be the early morning assessment at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02014142 on ClinicalTrials.gov Archive Site
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Comparison of Latanoprost PPDS With Timolol Maleate GFS in Subjects With Ocular Hypertension or Open-Angle Glaucoma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Ocular Hypertension
  • Open-Angle Glaucoma
  • Drug: Latanoprost Punctal Plug Delivery System (L-PPDS)
    Latanoprost Punctal Plug Delivery System (L-PPDS)
  • Drug: Timolol Maleate GFS, 0.5%
    Timolol Maleate GFS, 0.5%
  • 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.
    Intervention: Drug: 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.
    Intervention: Drug: Latanoprost Punctal Plug Delivery System (L-PPDS)
  • Active Comparator: Group D. Timolol Maleate GFS, 0.5%
    Timolol Maleate GFS drops; One drop timolol maleate ophthalmic GFS 0.5% QAM for 14 weeks.
    Intervention: Drug: Timolol Maleate GFS, 0.5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Brittany Brown 701-483-3599 ext 105 brittanybrown@trialrunners.com
Contact: Bob Butchofsky bbutchofsky@matitherapeutics.com
United States
 
NCT02014142
PPL GLAU M1
Not Provided
Mati Therapeutics Inc.
Mati Therapeutics Inc.
Not Provided
Not Provided
Mati Therapeutics Inc.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP