Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Nephron Pharmaceuticals Corporation
Sponsor:
Information provided by (Responsible Party):
Nephron Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT02059278
First received: February 7, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84 days in patients with elevated eye pressure.


Condition Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertenstion
Drug: T-2345
Drug: Xalatan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Parallel-Group, Observer-Masked, Phase 3 Study to Compare the Safety and Efficacy of T-2345 Ophthalmic Solution to Xalatan (Latanoprost 0.005%) in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Nephron Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    Evaluation of intraocular pressure using Goldmann applanation tonometry.


Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
    Corrected Snellen Visual Acuity measurement will be performed at all study visits with the Snellen eye chart using the subject's current corrective lens prescription at a distance equivalent to 20 feet (6 meters)

  • Slit Lamp Examination [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
    A routine slit lamp examination will be performed in at all study visits to evaluate the anterior segment of the eye, including lids, cornea, conjunctiva, anterior chamber, iris, and lens

  • Ophthalmoscopy [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
    Direct ophthalmoscopy with dilation will include assessment of the optic nerve head for pallor and cupping. A dilated fundus examination consisting of the vitreous, optic nerve, macula, and peripheral retina will be conducted.

  • Visual Field Testing [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
    The 30-2 or 24-2 test will be performed using an automated perimeter

  • Safety [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
    Adverse events, ocular comfort and tolerability will be assessed throughout the study


Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T-2345
T-2345 Ophthalmic Solution dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes)
Drug: T-2345
T-2345 Ophthalmic Solution
Experimental: Xalatan
Xalatan (Latanoprost 0.005% Ophthalmic Solution) dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes)
Drug: Xalatan
Xalatan (latanoprost 0.005% ophthalmic solution)

Detailed Description:

The objective of this Phase 3 study is to evaluate the efficacy and safety of T-2345 nonpreserved ophthalmic solution (latanoprost 0.005%) in comparison to Xalatan® (latanoprost 0.005%) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH).

This will be a randomized, multicenter, parallel-group, observer-masked study in approximately 380 evaluable subjects treated for 84 days. Subjects will have a history of POAG or OH and elevated intraocular pressure (IOP) and will have been adequately controlled (IOP ≤ 18 mm Hg) on latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks.

Primary efficacy (IOP) will be assessed in the study eye at each visit by Goldmann applanation tonometry at all assessment visits.

Safety will be assessed at each visit by corrected Snellen Visual Acuity, slit lamp examination/anterior chamber cell count and flare and adverse event (AE) collection.

Primary Efficacy Endpoint is the between-group comparison of the mean IOP values at each time point at each of the Day 15, 42, and 84 visits.

Secondary Efficacy Endpoints include:

  • Between-group comparison of the mean change from baseline in diurnal IOP measurements at all postbaseline visits.
  • Between-group comparison of the mean change from baseline in IOP measurements at all times points at Day 15, Day 42 and Day 84.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older.
  2. POAG or OH with IOP treated and adequately controlled (IOP ≤ 18 mm Hg) with latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks prior to Screening.
  3. Each eye being treated with latanoprost 0.005% ophthalmic solution monotherapy must have mean IOP ≤ 18 mm Hg at Screening and mean IOP ≤ 28 mm Hg at Baseline; measurements will be taken at each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes) with AM measurements of IOP at least 2 hours apart. If only one eye qualifies but both eyes have glaucoma and the fellow eye will require antiglaucoma medications, the subject does not qualify for the trial.
  4. Stable visual field (VF), defined as no sign of VF degradation between two consecutive 30-2 or two consecutive 24-2 VF examinations. For subjects with no VF defect (eg, those with OH), a single, normal VF examination performed ˂ 6 months prior to the screening visit is allowed to determine eligibility. For patients who have an abnormal VF examination, the following criteria apply:

    • Two VF (most recent VF and past VF) examinations performed at least ≥ 6 months and ≤ 18 months apart must be compared;
    • The most recent VF examination should be performed < 6 months prior to the Screening visit;
    • The past VF examination should be performed ≥ 6 months and ≤ 18 months prior to the most recent VF test.
  5. Stable corrected Snellen visual acuity (VA) of better than 20/200 in the study eye. Patients must see ≥ 50% of the letters on a single line to accept that VA line.
  6. Central corneal thickness 480-620 μm in the study eye.
  7. Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.
  8. Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Screening. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
  9. All subjects must provide signed written consent prior to participation in any study-related procedures.

Exclusion Criteria:

In the study eye:

  1. A mean deviation of < -20 dB on VF examination.
  2. A mean IOP ˃ 28 mm Hg at Baseline.
  3. Presence of a scotoma within 5° of fixation on VF examination.
  4. Aphakia.
  5. Use of any antiglaucoma medication in addition to latanoprost 0.005% ophthalmic solution within 2 weeks prior to Screening and any antiglaucoma medication (other than latanoprost) during the study period other than the randomized study medication.
  6. Use of any topical ophthalmic steroid within 2 weeks prior to Baseline. A short course of oral steroids is acceptable if the course is completed > 2 weeks prior to Screening. Inhaled and intranasal steroids are acceptable.
  7. Use of topical nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Baseline.
  8. Use of any ophthalmic medications during the study period (nonpreserved artificial tears are allowed).
  9. Ocular surgery or laser treatment of any kind in the study eye within 3 months prior to Baseline.
  10. History of ocular allergy/inflammation and/or severe blepharitis and/or uveitis. Seasonal allergic conjunctivitis is acceptable (avoid enrollment of subjects who may experience seasonal flare-up during the study period). Mild blepharitis/blepharoconjunctivitis, typically associated with prostaglandin usage, on the lid is acceptable.
  11. History of ocular trauma or ocular infection within 3 months of Screening.
  12. History of herpes simplex keratitis.
  13. Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
  14. Severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial erosions of the cornea, and/or use of dry eye medication [including artificial tears] with a frequency exceeding 8 instillations per day).
  15. Contact lens wear during the study period. Contact lens wear in an untreated fellow eye is allowed.
  16. Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
  17. Any severe glaucoma defined by cupping (cup-to-disc ratio ≥ 0.8).
  18. Any non-laser glaucoma surgery.
  19. Any abnormality preventing accurate assessment (eg, resulting in unreliable applanation tonometry or VF examination).

    General:

  20. Pregnancy or lactation.
  21. Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline-directed therapy).
  22. Allergy to benzalkonium chloride.
  23. History of moderate or severe renal or hepatic impairment.
  24. Participation in any study of an investigational product within 30 days prior to Screening or at any time during the study period.
  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: NCT02059278

Contacts
Contact: Drey Coleman 813-443-0974 dcoleman@pointguardllc.com

  Hide Study Locations
Locations
United States, Arizona
Little Rock Eye Center Recruiting
Little Rock, Arizona, United States, 72205
Contact: Shauna Pritchett    501-712-2516    shauna.pritchett@littlerockeye.com   
Principal Investigator: Charles Henry, MD         
United States, California
Sall Research Medical Center Not yet recruiting
Artesia, California, United States, 90701
Contact: Cindy Lee    562-804-1974    sallcindy@yahoo.com   
Principal Investigator: Ken Sall, MD         
North Bay Eye Recruiting
Petaluma, California, United States, 94954
Contact: Angela Lewis    707-769-2240    Alewis@northbayeye.com   
Principal Investigator: Jason Bacharach, MD         
United States, Colorado
Specialty Eye Center Recruiting
Parker, Colorado, United States, 80134
Contact: Elizabeth Salinas    303-794-1111    elizabeth@glaucdocs.com   
Principal Investigator: Charles McMahon, MD         
United States, Connecticut
Danbury Eye Physicians and Surgeons Recruiting
Danbury, Connecticut, United States, 06810
Contact: Pat Stenko    203-791-2020    clinicaleye@danburyeye.com   
Principal Investigator: Paul Matthew, MD         
Connecticut Eye Specialists Recruiting
Shelton, Connecticut, United States, 06484
Contact: Cara Deschaine    203-926-1700    cdeschaine@ctispec.com   
Principal Investigator: Joseph Sokol, MD         
United States, Florida
The Eye Associates of Manatee Recruiting
Bradenton, Florida, United States, 34209
Contact: Karen Hagin    941-792-2020    khagin@theeyeassociates.com   
Principal Investigator: Robert Friedman, MD         
International Research Center Recruiting
Brandon, Florida, United States, 33602
Contact: Michelle Whidden    813-875-6588    michellew@irctampa.com   
Principal Investigator: Bernard Perez, MD         
Hernando Eye Institute Recruiting
Brooksville, Florida, United States, 34613
Contact: Carol Smith    352-596-4030    carol.hernandoeye@tampabay.rr.com   
Principal Investigator: Leonard Cacioppo, MD         
Nature Coast Clinical Research Recruiting
Crystal River, Florida, United States, 34429
Contact: Nina Smith    352-563-1865    nsmith@encoredocs.com   
Principal Investigator: John Rowda, MD         
United States, Georgia
Clayton Eye Center Recruiting
Morrow, Georgia, United States, 30260
Contact: Helen Dubiner    404-520-1111    helendubiner@hotmail.com   
Principal Investigator: Harvey Dubiner, MD         
Coastal Research Associates Recruiting
Roswell, Georgia, United States, 30076
Contact: John Schuhr    770-777-1928    john@coastalresearchassociates.com   
Principal Investigator: Doug Day, MD         
Thomas Eye Group Recruiting
Sandy Springs, Georgia, United States, 30328
Contact: Kathy Wynne    404-256-1507    kathyw@thomaseye.com   
Principal Investigator: Dana Wallace, MD         
United States, Illinois
Chicago Research Center Recruiting
Chicago, Illinois, United States, 60634
Contact: Eric Malm    773-282-9845    eric.malm@chicagoresearchcenter.com   
Principal Investigator: David Hillman, MD         
United States, Kentucky
Taustine Eye Center Recruiting
Louisville, Kentucky, United States, 40217
Contact: Bridget Adkins    502-458-9004    eyeresearch@taustineeyecenter.com   
Principal Investigator: Gregory Sulkowski, MD         
United States, Michigan
Great Lakes Eye Center Recruiting
St Joseph, Michigan, United States, 49085
Contact: Marilyn Herrman    269-428-3300    mherrman@greateyecare.com   
Principal Investigator: David Cooke, MD         
United States, Missouri
Comprehensive Eye Care Recruiting
Washington, Missouri, United States, 63090
Contact: Renee Zeitzmann    636-390-3999    rzeitzmann@geccobilling.com   
Principal Investigator: Michael Korenfeld, MD         
United States, New York
Koffler Vision Group Recruiting
Lexington, New York, United States, 40509
Contact: Melissa Barnes    859-263-4631    mbarnes@kofflervisiongroup.com   
Principal Investigator: Bruce Koffler, MD         
Rochester Ophthalmological Group Recruiting
Rochester, New York, United States, 14618
Contact: Mindy VanVoorhis    585-244-6011    rogstudy@rogeyecare.com   
Principal Investigator: Paul Hartman, MD         
United States, North Carolina
Charlotte Eye Ear Nose and Throat Accociates Recruiting
Charlotte, North Carolina, United States, 28012
Contact: Angela Price    704-295-3390    aprice@ceenta.com   
Principal Investigator: Robert Flores, MD         
Mundorf Eye Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Michelle Mundorf    704-334-3222    michellemundorf@bellsouth.net   
Principal Investigator: Tom Mundorf, MD         
Cornerstone Eye Care Recruiting
High Point, North Carolina, United States, 27262
Contact: Cindy Wood    336-802-2255    cindy.wood@cornerstonehealthcare.com   
Principal Investigator: Michael Tepedino, MD         
United States, Ohio
Apex Eye (Madeira) Recruiting
Cincinnati, Ohio, United States, 45243
Contact: Amy Hoffman    513-561-5655    Amy.Hoffman@ApexEye.com   
Principal Investigator: Robert Benza, MD         
Apex Eye (Western Hills) Recruiting
Cincinnati, Ohio, United States, 45238
Contact: Barbara Henry    513-661-3566    Barbara.henry@ApexEye.com   
Principal Investigator: Mark Bergmann, MD         
Apex Eye (Kenwood) Recruiting
Cincinnati, Ohio, United States, 45236
Contact: Candace William    513-745-9787    candace.williams@ApexEye.com   
Principal Investigator: Karen Klugo, MD         
United States, South Carolina
Center for Eye Research Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Terri Pruitt    843-884-1011    terripruitt@gmail.com   
Principal Investigator: Elizabeth Sharpe, MD         
United States, Tennessee
Chattanooga Eye Institute Recruiting
Chattanooga, Tennessee, United States, 37411
Contact: Tracy Lippard    423-892-3937    research@chatteye.com   
Principal Investigator: Charles Kirby, MD         
United States, Texas
The Cataract and Glaucoma Center Recruiting
El Paso, Texas, United States, 79902
Contact: Terry Cintron    915-545-2333    tcintron@dralpern.com   
Principal Investigator: Louis Alpern, MD         
R and R Eye Research Recruiting
San Antonio, Texas, United States, 78229
Contact: Anita Holland    210-340-1212    ANITA@rreyes.net   
Principal Investigator: William Flynn, MD         
Eye Clinics of South Texas Recruiting
San Antonio, Texas, United States, 78209
Contact: Marcie Smith    210-826-2012    EYECLINICS3@SBCGOBAL.NET   
Principal Investigator: Jay Rubin, MD         
Sponsors and Collaborators
Nephron Pharmaceuticals Corporation
  More Information

No publications provided

Responsible Party: Nephron Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT02059278     History of Changes
Other Study ID Numbers: T-2345-001
Study First Received: February 7, 2014
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Nephron Pharmaceuticals Corporation:
Primary open angle glaucoma
Ocular hypertenstion

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014