CataractPhase 3NCT00687791
Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
A Phase 3 study testing ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery in people with Cataract and Glaucoma, run by Pro Top & Mediking Company Limited at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or over.
- At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
- Visually significant cataract with visual acuity of less than or equal to 6/12.
- Subject able and willing to cooperate with investigation plan.
- Subject willing to sign informed consent form.
Who cannot join
- Known allergic reaction to collagen.
- Subject is on Warfarin and discontinuation is not recommended.
- Subject with normal tension glaucoma or aphakic glaucoma.
- Subject with corneal disease.
- Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
- Ocular infection within 14 days prior to phacotrabeculectomy.
- Pregnant or breast-feeding women.
- Monocular subject.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore Eye Research Institute
Singapore, 168751
About this study
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.
Read the detailed 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
- Being tested
- ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
- Keywords
- patients with cataract and glaucoma, ologen, oculusgen, collagen matrix, Phacotrabeculectomy, Aeon Astron, trabeculectomy, tissue engineering, mitomycin-C
- Medical subject headings
- Cataract, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgeryDevice
Also called OculusGen (ologen™)
Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20 enrolled patients will be chosen according to the enrollment acceptance criteria. The evidence for the determination of enrolled patients shall be recorded, reviewed and approved. 2> Phacotrabeculectomy is performed.3> After completing phacotrabeculectomy, implant/place ologen™ Collagen Matrix on top of the scleral flap under the conjunctiva. For every inspection and observation, the detailed description and/or inspection data shall be recorded. If any unwanted adverse event is observed during inspection and observation, it shall be recorded and be reported to the investigation conductor. Receives: Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to prove the effectiveness via the reduction of IOP.
Measured: 180 days
Secondary outcomes (1)
the secondary endpoint is to prove the safety via the reduction of complications.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pro Top & Mediking Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Aung Tin, PhD MD, Study chair, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687791
- Sponsor's protocol ID
- Mediking 0706
- Status last verified
- Jun 2008
- First submitted
- 28 May 2008
- Last updated
- 18 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
- ClinicalTrials.gov ID
- NCT00687791
- Acronym / sponsor ID
- Mediking 0706
- Keywords
- patients with cataract and glaucoma, ologen, oculusgen, collagen matrix, Phacotrabeculectomy, Aeon Astron, trabeculectomy, tissue engineering
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pro Top & Mediking Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery20 enrolled patients will be chosen according to the enrollment acceptance criteria. The evidence for the determination of enrolled patients shall be recorded, reviewed and approved. 2> Phacotrabeculectomy is performed.3> After completing phacotrabeculectomy, implant/place ologen™ Collagen Matrix on top of the scleral flap under the conjunctiva. For every inspection and observation, the detailed description and/or inspection data shall be recorded. If any unwanted adverse event is observed during inspection and observation, it shall be recorded and be reported to the investigation conductor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or over.
- At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
- Visually significant cataract with visual acuity of less than or equal to 6/12.
- Subject able and willing to cooperate with investigation plan.
- Subject willing to sign informed consent form.
Key exclusion criteria (8 listed)
- Known allergic reaction to collagen.
- Subject is on Warfarin and discontinuation is not recommended.
- Subject with normal tension glaucoma or aphakic glaucoma.
- Subject with corneal disease.
- Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgeryAlso: OculusGen (ologen™)Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery | Device | 1 |
Primary outcome
The primary endpoint is to prove the effectiveness via the reduction of IOP.
Time frame: 180 days
1 secondary outcome
the secondary endpoint is to prove the safety via the reduction of complications.
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aung Tin, PhD MD study chair
Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery in people with Cataract and Glaucoma, run by Pro Top & Mediking Company Limited at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aung Tin, PhD MD (+65-62277255, aung.tin@snec.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is to prove the effectiveness via the reduction of IOP. (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2008.