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

Ocular Surface Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254370
• Other study ID #: NVG10E118
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2010
• Last updated: June 5, 2015
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2015
• Source: Novagali Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma or Ocular Hypertension and
• Hypertension
• Ocular Hypertension
• Ocular Surface Disease

Intervention

Drug:
• Latanoprost
0.005%
• Travatan Z
0.004%

Locations

Country	Name	City	State
United States	Ora (Ophthalmic Research Associates)	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novagali Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Catioprost versus Travatan Z	Efficacy measures: Change from baseline in Intraocular Pressure (IOP); Change in Ocular Surface Disease (OSD)	3 months	No