Evaluation of Safety 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:
NCT00945958
First received: July 23, 2009
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the long-term safety of a Latanoprost ophthalmic solution, a multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: Latanoprost
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of Safety of Latanoprost Ophthalmic Solution When Administered Once Daily in Subjects With Open Angle Glaucoma or Ocular Hypertension: an Open Label Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Adverse event and Serious adverse events evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intraocular Pressure, Slit Lamp Biomicroscopy, Perimetry [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Latanoprost
    Latanoprost eye drops, one drop in affected eye, once daily, 24 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
  • Willing to participate and giving written informed consent
  • Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
  • Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma

Exclusion Criteria:

  • History of allergic hypersensitivity or poor tolerance to latanoprost
  • History of Substance abuse or addiction (alcohol drugs) in the past 3 years
  • History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication
  • Any abnormality preventing IOP measurement
  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: NCT00945958

Locations
United States, North Carolina
Cornerstone Eye Care
High Point, North Carolina, United States, 27262
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: NCT00945958     History of Changes
Other Study ID Numbers: CLR_09_13
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
Ocular hypertension

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 26, 2014