NCT00947661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
578

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

May 30, 2016

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

July 23, 2009

Results QC Date

December 14, 2015

Last Update Submit

March 6, 2021

Conditions

Open Angle GlaucomaOcular Hypertension

Keywords

glaucoma latanoprost

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 weeks

Study Arms (2)

SPARC0912

EXPERIMENTAL

Test drug

Drug: SPARC0912

Reference0912

EXPERIMENTAL

Reference drug

Drug: Reference0912

Interventions

SPARC0912DRUG

Eye drops, once daily, 12 weeks

SPARC0912
Reference0912DRUG

Eye drops, once daily, 12 weeks

Reference0912

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPARC study site

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Results Point of Contact

Title
Dr Shravanti Bhowmik
Organization
Sun Pharma Advanced Research Company
shravanti.bhowmik@sparcmail.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 28, 2009

Study Start

July 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 9, 2021

Results First Posted

May 30, 2016

Record last verified: 2021-03

Locations

US(1)