Ologen (OculusGen)-Glaucoma MMC Control Trial in India

This study is currently recruiting participants.

Verified October 2011 by Pro Top & Mediking Company Limited

Sponsor:

Information provided by (Responsible Party):

Pro Top & Mediking Company Limited

ClinicalTrials.gov Identifier:

NCT00449098

First received: March 15, 2007

Last updated: October 6, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 15, 2007

Last Updated Date

October 6, 2011

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the effectiveness via the reduction of IOP [ Time Frame: 180 day ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

IOP < 21mmHg with no glaucoma medications on the day of 180th after surgery and at least a 20% reduction from baseline IOP.

Change History

Complete list of historical versions of study NCT00449098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

the safety via the incidence of complications and adverse events. [ Time Frame: 180 day ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

IOP < 21mmHg with glaucoma medications, or IOP ≧ 21 mmHg but reduction of IOP greater than or equal to 30% with/without glaucoma medications

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ologen (OculusGen)-Glaucoma MMC Control Trial in India

Official Title ^ICMJE

Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Brief Summary

The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

Detailed Description

Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with ologen (OculusGen) implant or trabeculectomy with mitomycin-C.
Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

Device: OculusGen Biodegradable Collagen Matrix Implant
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
Drug: Trabeculectomy with MMC
Trabeculectomy with MMC

Study Arm (s)

Experimental: OculusGen Biodegradable Collagen Matrix Implant
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant

Intervention: Device: OculusGen Biodegradable Collagen Matrix Implant
Active Comparator: MMC
Trabeculectomy with MMC

Intervention: Drug: Trabeculectomy with MMC

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 18 years or over.
Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
Subject able and willing to cooperate with investigation plan.
Subject able and willing to complete postoperative follow-up requirements.
Subject willing to sign informed consent form.

Exclusion Criteria:

Known allergic reaction to mitomycin-C or porcine collagen.
Subject is on warfarin and discontinuation is not recommended.
Normal tension glaucoma.
Participation in an investigational study during the 30 days preceding trabeculectomy.
Ocular infection within 14 days prior to trabeculectomy.
Pregnant or breast-feeding women.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Arslan Tsai, Pharma

+886 2 27088558 ext 116

arslan.tsai@aeonastron.net

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00449098

Other Study ID Numbers ^ICMJE

Mediking 0701, OculusGen-2006-02-20

Has Data Monitoring Committee

Not Provided

Responsible Party

Pro Top & Mediking Company Limited

Study Sponsor ^ICMJE

Pro Top & Mediking Company Limited

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rajul S Parikh, MD

V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,

Information Provided By

Pro Top & Mediking Company Limited

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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