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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02059278
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Nephron Pharmaceuticals Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Drug: T-2345 Drug: Xalatan Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 84 days ]
    Evaluation of intraocular pressure using Goldmann applanation tonometry.

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 84 days ]
    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)

  2. Slit Lamp Examination [ Time Frame: 84 days ]
    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

  3. Ophthalmoscopy [ Time Frame: 84 days ]
    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.

  4. Visual Field Testing [ Time Frame: 84 days ]
    The 30-2 or 24-2 test will be performed using an automated perimeter

  5. Safety [ Time Frame: 84 days ]
    Adverse events, ocular comfort and tolerability will be assessed throughout the study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02059278

United States, Texas
El Paso, Texas, United States
Sponsors and Collaborators
Nephron Pharmaceuticals Corporation

Responsible Party: Nephron Pharmaceuticals Corporation Identifier: NCT02059278     History of Changes
Other Study ID Numbers: T-2345-001
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents