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Safety and Efficacy Study of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® to Treat Glaucoma and Ocular Surface Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novagali Pharma
ClinicalTrials.gov Identifier:
NCT01254370
First received: November 29, 2010
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to compare:

  • the effect of Catioprost® and Travatan Z® on the ocular surface disease (OSD) in subjects with glaucoma or ocular hypertension and ocular surface disease.
  • the intraocular pressure (IOP) lowering effect and safety of Catioprost® and Travatan Z® in subjects with glaucoma or ocular hypertension and ocular surface disease.

Condition Intervention Phase
Glaucoma or Ocular Hypertension and
Ocular Surface Disease
Drug: Latanoprost
Drug: Travatan Z
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized Study Evaluating the Safety and Efficacy of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® in Subjects With Glaucoma or Ocular Hypertension and Ocular Surface Disease

Resource links provided by NLM:


Further study details as provided by Novagali Pharma:

Primary Outcome Measures:
  • Efficacy and Safety of Catioprost versus Travatan Z [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    Efficacy measures:

    • Change from baseline in Intraocular Pressure (IOP)
    • Change in Ocular Surface Disease (OSD)

    Safety measures:

    • Slit Lamp Biomicroscopy
    • Dilated Fundus Exam, including C/D ratio
    • Best Corrected Visual Acuity (BCVA)
    • Assessment of Adverse Events


Enrollment: 105
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Catioprost Drug: Latanoprost
0.005%
Active Comparator: Travatan Z Drug: Travatan Z
0.004%

  Eligibility

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

Inclusion Criteria:

  • Be at least 18 years of age at Visit 1 (IOP Screening), of either sex and any race or ethnicity.
  • Be willing and able to provide written informed consent prior to any study procedures being performed.
  • Be willing and able to follow all instructions and attend all study visits.
  • Have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or chronic angle closure glaucoma with a patent iridotomy requiring treatment with an ocular hypertensive therapy in the study eye.
  • Agree to submit to a pregnancy test at Visit 1 and at Visit 4, or not be of childbearing potential.
  • Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential. Acceptable methods of birth control include: spermicide with barrier, oral, transdermal, injectable, or implantable contraception, IUD, abstinence, and surgical sterilization of partner. Female subjects are not of childbearing potential if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or are post-menopausal by at least 12 months.

Exclusion Criteria:

  • Have known sensitivity or poor tolerance to latanoprost or travoprost or any other component of the study medications.
  • Have any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component), ocular hypertension or chronic angle closure glaucoma with patent iridotomy in either eye.
  • Have an IOP at any time point during the Screening or Baseline visits (Visits 1 or 2) of > 34 mmHg in either eye.
  • Be currently pregnant, nursing, or planning a pregnancy during the study period; or be a woman that has a positive pregnancy test.
  • Have a history of any significant ocular condition(s) in either eye that would contraindicate the use of latanoprost or travoprost, or that might affect the study conduct or the interpretation of the study results.
  • Have any abnormality preventing reliable Goldmann applanation tonometry of either eye.
  • Have been previously non-responsive to prostaglandin analog therapy for reduction of IOP.
  • Have prior (within 30 days of Visit 1) or anticipated concurrent use of an investigational drug or device during the study period.
  • Have a condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
  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: NCT01254370

Locations
United States, Massachusetts
Ora (Ophthalmic Research Associates)
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Novagali Pharma
  More Information

No publications provided

Responsible Party: Novagali Pharma
ClinicalTrials.gov Identifier: NCT01254370     History of Changes
Other Study ID Numbers: NVG10E118
Study First Received: November 29, 2010
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Latanoprost
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014