Trial Outcomes & Findings for Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery (NCT NCT00538590)

NCT ID: NCT00538590

Last Updated: 2012-04-25

Results Overview

Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 360 days
• Results posted on: 2012-04-25

Participant Flow

Participant milestones

Measure	MITOMYCIN-C Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	MITOMYCIN-C Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Overall Study Death	1	0

Baseline Characteristics

Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

Baseline characteristics by cohort

Measure	MITOMYCIN-C n=10 Participants Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) n=10 Participants The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age Continuous	60.6 years STANDARD_DEVIATION 9.4 • n=5 Participants	64.9 years STANDARD_DEVIATION 8.6 • n=7 Participants	62.8 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Germany	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 360 days

Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Outcome measures

Measure	MITOMYCIN-C n=9 Participants Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) n=10 Participants The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Postoperative Intraocular Pressure Change	-11.3 mm Hg Standard Deviation 8.7	-11.6 mm Hg Standard Deviation 9.9

PRIMARY outcome

Timeframe: 180 days

Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Outcome measures

Measure	MITOMYCIN-C n=10 Participants Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) n=10 Participants The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Postoperative Intraocular Pressure Change	-11.8 mm Hg Standard Deviation 6.1	-11.8 mm Hg Standard Deviation 11.2

PRIMARY outcome

Timeframe: 90 days

Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Outcome measures

Measure	MITOMYCIN-C n=10 Participants Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) n=10 Participants The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Postoperative Intraocular Pressure Change	-10.9 mm Hg Standard Deviation 5.8	-14.1 mm Hg Standard Deviation 10.1

PRIMARY outcome

Timeframe: 30 days

Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

Outcome measures

Measure	MITOMYCIN-C n=10 Participants Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) n=10 Participants The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Postoperative Intraocular Pressure Change	-13.3 mm Hg Standard Deviation 6.4	-12.9 mm Hg Standard Deviation 8.6

SECONDARY outcome

Timeframe: 360 days

Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.

Outcome measures

Measure	MITOMYCIN-C n=9 Participants Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) n=10 Participants The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Complications	15.6 percentage of participants Standard Deviation 10.1	15.6 percentage of participants Standard Deviation 20.1

Adverse Events

MITOMYCIN-C

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Ologen (Oculusgen)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	MITOMYCIN-C n=10 participants at risk Application of Mitomycin-C in trabeculectomy to reduce super-scarring.	Ologen (Oculusgen) n=10 participants at risk The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Cardiac disorders Death	10.0% 1/10 • Number of events 1	0.00% 0/10

Other adverse events

Adverse event data not reported

Additional Information

Thomas Dietlein, Ph. D., MD

Hospital of Universität Köln

Phone: +49 221 4785862

Email: thomas.dietlein@uk-koeln.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place