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

This study has been completed.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: July 23, 2009
Last updated: May 30, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
Drug: SPARC0912
Drug: Reference0912
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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Reduction in Intraocular Pressure From Baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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)

Enrollment: 578
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
Experimental: SPARC0912
Test drug
Drug: SPARC0912
Eye drops, once daily, 12 weeks
Experimental: Reference0912
Reference drug
Drug: Reference0912
Eye drops, once daily, 12 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00947661

United States, North Carolina
SPARC study site
North Carolina, North Carolina, United States
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT00947661     History of Changes
Other Study ID Numbers: CLR_09_12 
Study First Received: July 23, 2009
Results First Received: December 14, 2015
Last Updated: May 30, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases processed this record on October 21, 2016