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

November 29, 2010
May 13, 2013
November 2010
June 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01254370 on ClinicalTrials.gov Archive Site
Not Provided
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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
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Glaucoma or Ocular Hypertension and
  • Ocular Surface Disease
  • Drug: Latanoprost
    0.005%
  • Drug: Travatan Z
    0.004%
  • Experimental: Catioprost
    Intervention: Drug: Latanoprost
  • Active Comparator: Travatan Z
    Intervention: Drug: Travatan Z
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01254370
NVG10E118
Not Provided
Novagali Pharma
Novagali Pharma
Not Provided
Not Provided
Novagali Pharma
May 2013

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