Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alleanza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01896180
First received: July 8, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

This is a pilot, proof of concept study to evaluate the safety and efficacy of ALZ-1101 dosed once daily for 28 days compared to latanoprost 0.005% ophthalmic solution in patients with elevated intraocular pressure not adequately controlled with latanoprost.


Condition Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
Elevated Intraocular Pressure
Drug: ALZ-1101
Drug: Latanoprost
Phase 2

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 Pilot, Single-Masked Study to Compare the Safety and Efficacy of ALZ-1101 (Latanoprost 0.005%/Dorzolamide 2.0%) to Latanoprost Ophthalmic Solution, 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension With Intraocular Pressure Inadequately Controlled By Latanoprost

Resource links provided by NLM:


Further study details as provided by Alleanza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Goldmann applanation tonometry [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Between-group comparison of the mean IOP values at the 10 AM time point at Visit 5 (Day 28).


Secondary Outcome Measures:
  • Goldmann applanation tonometry [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Between-group comparison of the mean change from baseline in IOP at all time points at all post-baseline visits

  • Goldmann applanation tonometry [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Between-group comparison of the mean change from baseline in diurnal IOP at all post baseline visits

  • Goldmann applanation tonometry [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The proportion of subjects with IOP ≤ 18 mm Hg at all time points at all post-baseline visits

  • Safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Assessment of the safety and tolerability will be assessed by slit lamp examination/anterior chamber cell and flare grading, ophthalmoscopy (cup-to-disc ratio)/dilated fundus examination, corrected Snellen visual acuity, VF testing, and adverse event assessment. Comfort data (subjective) will also be collected at each visit.


Enrollment: 63
Study Start Date: July 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALZ-1101
ALZ-1101 ophthalmic solution dosed as 1 drop, once daily in the evening via topical ocular adminstration
Drug: ALZ-1101
ALZ-1101 Ophthalmic Solution
Active Comparator: Latanoprost
Latanoprost 0.005% ophthalmic solution dosed as 1 drop, once daily in the evening via topical ocular administration
Drug: Latanoprost
Latanoprost 0.005% Ophthalmic Solution

Detailed Description:

This is an exploratory, pilot, proof of concept Phase 2 study. The objectives include the comparison of efficacy of ALZ-1101 to latanoprost 0.005% ophthalmic solution in reducing elevated intraocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension who have IOP not adequately controlled with latanoprost.

70 Subjects (35 per arm) will be treated once daily (QD) in the evening with either ALZ-1101 or latanoprost for 28 days.

Efficacy will be assessed at 3 separate times (8 AM, 10 AM and 4 PM) on each treatment visit (Days 0, 7, 14 and 28) by Goldmann applanation tonometry.

Safety assessments will include slit lamp examination/anterior chamber cell and flare grading, ophthalmoscopy/fundus examination, visual acuity, visual field testing and colelction of adverse events. Subject rating of study medication comfort will be collected at each visit.

Primary efficacy endpoint is the between-group comparison of the mean IOP at the 10 am time point at visit 5 (Day 28). Secondary endpoints include the between-group comparisons of the mean change from baseline in IOP at all time-points, between group comparison of the mean change from baseline in diurnal IOP at all post-baseline visits and the proportion of subjects with IOP ≤ 18 mm Hg at all time points at all post-baseline visits.

  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. Primary open-angle glaucoma or OH on treatment with latanoprost 0.005% QD.
  3. At least one eye with IOP > 18 mm Hg but ≤ 28 mm Hg at all time points (8 AM, 10 AM, and 4 PM) while on latanoprost monotherapy QD at Screening and Baseline (Day 0) visits. Measurements will be taken each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes), with AM measurements of IOP at least 2 hours apart. Screening must be at least one week before but within 2 weeks prior to Baseline.
  4. On latanoprost 0.005% QD for at least 4 weeks prior to randomization.
  5. Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.
  6. Stable corrected Snellen visual acuity (VA) better than 20/200 in the study eye.
  7. Central corneal thickness between 480-620 μm in the study eye.
  8. Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. 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. Provide signed written consent prior to participation in any study-related procedures.

Exclusion Criteria:

  1. A mean deviation of < -20 dB on visual field (VF) assessment.
  2. Presence of a scotoma within 5°of fixation on VF.
  3. Aphakia.
  4. Use of any antiglaucoma medication in addition to latanoprost QD within 2 weeks prior to Visit 1 or during the study period.
  5. Use of any topical ophthalmic steroid or nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Visit 1 or during the study period.
  6. Use of systemic carbonic anhydrase inhibitor within 2 weeks prior to Visit 1 or during the study period.
  7. Ocular surgery or ocular laser treatment of any kind within 3 months prior to Visit 1 or during the study period.
  8. Any history of glaucoma surgery (laser or non-laser).
  9. 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, is acceptable.
  10. History of ocular trauma or ocular infection within 3 months of Visit 1.
  11. History of herpes simplex keratitis.
  12. Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
  13. 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 applications per day).
  14. Contact lens wear within one week prior to Visit 1 or during the study period (contact lens wear in an untreated fellow eye is allowed).
  15. Angle closure or occludable angles (Shaffer gonioscopic grade of < 3).
  16. Cataract that compromises visualization of the fundus.
  17. Cup-to-disc (C/D) ratio of > 0.8.
  18. Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
  19. Pregnancy or lactation.
  20. Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline directed therapy).
  21. Allergy to prostaglandin analogues or carbonic anhydrase inhibitors.
  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 Visit 1 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: NCT01896180

Locations
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
United States, Georgia
Clayton Eye Center
Morrow, Georgia, United States, 30260
United States, Texas
Texan Eye/Keystone Research
Austin, Texas, United States, 78731
The Cataract and Glaucoma Center
El Paso, Texas, United States, 79902
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Alleanza Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Alleanza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01896180     History of Changes
Other Study ID Numbers: ALZ-1101-101
Study First Received: July 8, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alleanza Pharmaceuticals, Inc.:
POAG
OHT
OHTN
IOP

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

ClinicalTrials.gov processed this record on August 27, 2014