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

July 23, 2009
June 6, 2012
July 2010
May 2012   (final data collection date for primary outcome measure)
Intraocular pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00947661 on ClinicalTrials.gov Archive Site
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Efficacy and Safety of 2 Formulations of Latanoprost Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Open Angle Glaucoma
  • Ocular Hypertension
Drug: Formulation 2:Latanoprost (without BAC)
Eye drops, once daily, 12 weeks
  • Active Comparator: Formulation 1: Latanoprost (with BAC)
    Latanoprost with benzalkonium chloride as preservative
    Intervention: Drug: Formulation 2:Latanoprost (without BAC)
  • Experimental: Formulation 2: Latanoprost (without BAC)
    Latanoprost without benzalkonium chloride as preservative
    Intervention: Drug: Formulation 2:Latanoprost (without BAC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
590
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00947661
CLR_09_12
Not Provided
Sun Pharma Advanced Research Company Limited
Sun Pharma Advanced Research Company Limited
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
June 2012

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