Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study

Cataract Clinical Trial

Official title:

Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00687791
• Other study ID #: Mediking 0706
• Status: Recruiting
• Phase: Phase 3
• First received: May 28, 2008
• Last updated: June 17, 2008
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2008
• Source: Pro Top & Mediking Company Limited
• Contact: Aung Tin, PhD MD
• Phone: +65-62277255
• Email: aung.tin[@]snec.com.sg
• Is FDA regulated: No
• Health authority: Singapore: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy 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.

Description:

Ologen™ Collagen Matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditional filtering surgery (trabeculectomy)

Within 60 days from the time of implantation, ologen™ Collagen Matrix is totally degraded. Postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or over.

2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.

3. Visually significant cataract with visual acuity of less than or equal to 6/12.

4. Subject able and willing to cooperate with investigation plan.

5. Subject willing to sign informed consent form.

Exclusion Criteria:

1. Known allergic reaction to collagen.

2. Subject is on Warfarin and discontinuation is not recommended.

3. Subject with normal tension glaucoma or aphakic glaucoma.

4. Subject with corneal disease.

5. Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.

6. Ocular infection within 14 days prior to phacotrabeculectomy.

7. Pregnant or breast-feeding women.

8. Monocular subject.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Device:
• ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

Locations

Country	Name	City	State
Singapore	Singapore Eye Research Institute	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pro Top & Mediking Company Limited

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is to prove the effectiveness via the reduction of IOP.		180 days	No
Secondary	the secondary endpoint is to prove the safety via the reduction of complications.		180 days	Yes

External Links

•   Product background and description