- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00947661
Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
March 6, 2021 updated by: Sun Pharma Advanced Research Company Limited
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
578
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
High Point, North Carolina, United States, 27262
- SPARC study site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SPARC0912
Test drug
|
Eye drops, once daily, 12 weeks
|
EXPERIMENTAL: Reference0912
Reference drug
|
Eye drops, once daily, 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (ACTUAL)
May 1, 2012
Study Completion (ACTUAL)
May 1, 2012
Study Registration Dates
First Submitted
July 23, 2009
First Submitted That Met QC Criteria
July 24, 2009
First Posted (ESTIMATE)
July 28, 2009
Study Record Updates
Last Update Posted (ACTUAL)
March 9, 2021
Last Update Submitted That Met QC Criteria
March 6, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLR_09_12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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