NCT00449098.

Trial name or title	Ologen (OculusGen)‐Glaucoma MMC control trial in India
Methods	Study design: "interventional, randomized, parallel, open label clinical trial" Number randomized: 40 participants (number of eyes not reported) total; not reported by intervention group Unit of analysis: not reported Power calculation: not reported
Participants	Country: India Inclusion Criteria: Age 18 years or over. Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy Participant able and willing to cooperate with investigation plan Participant able and willing to complete postoperative follow‐up requirements Participant willing to sign informed consent form Exclusion Criteria: Known allergic reaction to mitomycin‐C or porcine collagen Participant 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
Interventions	Intervention 1: trabeculectomy + OculusGen Biodegradable Collagen Matrix Implant Intervention 2: trabeculectomy + MMC Length of follow‐up: planned: 180 days
Outcomes	Primary outcome, as defined in study reports: reduction of IOP at 180 days Secondary outcomes, as defined in study reports: incidence of complications and adverse events at 180 days Adverse events reported: this was planned Intervals at which outcomes assessed: "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"
Starting date	January 2007
Contact information	Rajul S Parikh, MD rajulparikh@lvpei.org L. V. Prasad Eye Institute, India
Notes	Funding source: not reported Last updated: October 6, 2011 This study is currently recruiting participants.