Efficacy and Safety of 2 Formulations of Latanoprost Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT00947661
First received: July 23, 2009
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of 2 formulations of Latanoprost Ophthalmic Solution. Formulation 1 is the currently marketed Latanoprost. Formulation 2 is an experimental Latanoprost with similar active ingredient but containing a different preservative as that in Formulation 1. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM. The study eye is defined as the eye with higher intraocular pressure (IOP) at enrollment or if equal, patients with an even randomization number will be assigned left eye and an odd number the right eye.


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: Formulation 2:Latanoprost (without BAC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of 2 Formulations of Latanoprost Ophthalmic Solution When Administered Once Daily in Subjects With Open Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 590
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Formulation 1: Latanoprost (with BAC)
Latanoprost with benzalkonium chloride as preservative
Drug: Formulation 2:Latanoprost (without BAC)
Eye drops, once daily, 12 weeks
Experimental: Formulation 2: Latanoprost (without BAC)
Latanoprost without benzalkonium chloride as preservative
Drug: Formulation 2:Latanoprost (without BAC)
Eye drops, once daily, 12 weeks

  Eligibility

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

Inclusion Criteria:

  • Men and women aged ≥ 18 years.
  • Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG).
  • Unmedicated IOP ≥ 22 mmHg in one or both eyes.
  • Given informed consent.
  • Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test.

Exclusion Criteria:

  • Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
  • Intraocular conventional surgery or laser surgery within the past six months.
  • Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
  • Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
  • Ocular trauma within the past 3 months.
  • Progressive retinal or optic nerve disease apart from glaucoma.
  • Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye.
  • Any abnormality preventing stable applanation tonometry.
  • Use of contact lens for the duration of the study.
  • Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
  • Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe.
  • Clinically significant systemic disease which might interfere with the study.
  • History of non-compliance to medical regimens or unwilling to comply with the study protocol.
  • Participation in another clinical study within the last thirty (30) days.
  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: NCT00947661

Locations
United States, Texas
David Shulman
San Antonio, Texas, United States
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT00947661     History of Changes
Other Study ID Numbers: CLR_09_12
Study First Received: July 23, 2009
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sun Pharma Advanced Research Company Limited:
glaucoma latanoprost

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

ClinicalTrials.gov processed this record on August 27, 2014