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

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SPARC0912
Reference0912
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring glaucoma latanoprost

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SPARC study site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SPARC0912

Reference0912

Arm Description

Test drug

Reference drug

Outcomes

Primary Outcome Measures

Change in Intraocular Pressure From Baseline to Week 12
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)

Secondary Outcome Measures

Full Information

First Posted
July 23, 2009
Last Updated
March 6, 2021
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00947661
Brief Title
Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
glaucoma latanoprost

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
578 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPARC0912
Arm Type
Experimental
Arm Description
Test drug
Arm Title
Reference0912
Arm Type
Experimental
Arm Description
Reference drug
Intervention Type
Drug
Intervention Name(s)
SPARC0912
Intervention Description
Eye drops, once daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Reference0912
Intervention Description
Eye drops, once daily, 12 weeks
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure From Baseline to Week 12
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
SPARC study site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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