Comparative Study of Ologen Collagen Matrix Versus Mitomycin-C in Glaucoma Filtering Surgery

Completed · Phase 4

Conditions studied: Glaucoma

In brief

The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) and Mitomycin-C (MMC) as adjuncts to filtration surgery in uncontrolled treated glaucoma cases, the efficacy being the primary objective and the safety being the secondary.

Key facts

Study ID

NCT01440751

Run by

Aeon Astron Europe B.V.

People needed

99

Starts

2011-09-01

Expected to finish

2015-12-01

Last updated by the study team

2017-11-01

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 30 years (inclusive)
• Uncontrolled treated glaucoma requiring trabeculectomy
• Subject must be able and willing to cooperate with investigation plan
• Subject must be able and willing to complete postoperative follow-up requirements
• subject must be willing to sign informed consent form

You may not qualify if…

• Known allergic reaction to MMC or porcine collagen
• Neovascular, uveitic, aphakic glaucoma, previous incisional glaucoma surgery
• Prior cataract unless clear corneal incision
• Previous conjunctival or strabismus surgery
• Participation in an investigational study during 30 days prior to trabeculectomy
• Ocular infection within 14 days prior to trabeculectomy
• Pregnant or breast-feeding women

Where it is running

• VoldVision-Holf Eye Clinic — Rogers, Arkansas, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Institue of Ophthalmology and Visual Science — Newark, New Jersey, United States
• Glaucoma Associates of New York — New York, New York, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• Dean McGee Eye Institue — Oklahoma City, Oklahoma, United States
• Wills Eye Institue — Philadelphia, Pennsylvania, United States
• Glaucoma Associates of Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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