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

• 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: Sun Pharma Advanced Research Company Limited
• Information provided by (Responsible Party): Sun Pharma Advanced Research Company Limited

Tracking Information

• First Submitted Date: July 23, 2009
• First Posted Date: July 28, 2009
• Results First Submitted Date: December 14, 2015
• Results First Posted Date: May 30, 2016
• Last Update Posted Date: October 27, 2016
• Study Start Date: July 2010
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: July 24, 2009): Intraocular pressure [ Time Frame: 12 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Open Angle Glaucoma
• Ocular Hypertension

Intervention

• Drug: SPARC0912
  Eye drops, once daily, 12 weeks
• Drug: Reference0912
  Eye drops, once daily, 12 weeks

Study Arms

• Experimental: SPARC0912
  Test drug
  Intervention: Drug: SPARC0912
• Experimental: Reference0912
  Reference drug
  Intervention: Drug: Reference0912

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 21, 2016): 578
• Original Estimated Enrollment (submitted: July 24, 2009): 200
• Actual Study Completion Date: May 2012
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00947661
• Other Study ID Numbers: CLR_09_12
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sun Pharma Advanced Research Company Limited
• Study Sponsor: Sun Pharma Advanced Research Company Limited
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sun Pharma Advanced Research Company Limited
• Verification Date: September 2016