Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947661
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : May 30, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Tracking Information
First Submitted Date  ICMJE July 23, 2009
First Posted Date  ICMJE July 28, 2009
Results First Submitted Date  ICMJE December 14, 2015
Results First Posted Date  ICMJE May 30, 2016
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
Change in Intraocular Pressure From Baseline to Week 12 [ Time Frame: 12 weeks ]
95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
Intraocular pressure [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE Not Provided
Brief Summary A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: SPARC0912
    Eye drops, once daily, 12 weeks
  • Drug: Reference0912
    Eye drops, once daily, 12 weeks
Study Arms  ICMJE
  • Experimental: SPARC0912
    Test drug
    Intervention: Drug: SPARC0912
  • Experimental: Reference0912
    Reference drug
    Intervention: Drug: Reference0912
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2016)
578
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2009)
200
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947661
Other Study ID Numbers  ICMJE CLR_09_12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sun Pharma Advanced Research Company Limited
Study Sponsor  ICMJE Sun Pharma Advanced Research Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Advanced Research Company Limited
Verification Date September 2016

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