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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma; Ocular Surface Disease
• Intervention / Treatment: Drug: Latanoprost; Drug: Travatan Z

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Ora (Ophthalmic Research Associates)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catioprost	Drug: Latanoprost; 0.005%
Active Comparator: Travatan Z	Drug: Travatan Z; 0.004%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Catioprost versus Travatan Z	Efficacy measures: Change from baseline in Intraocular Pressure (IOP); Change in Ocular Surface Disease (OSD)	3 months

Collaborators and Investigators

• Sponsor: Santen SAS

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (Estimate): December 6, 2010

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: May 26, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Travoprost; Latanoprost
• Other Study ID Numbers: NVG10E118