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NCT03506542
Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C
Phase 2 trial testing Ologen in Glaucoma in 53 participants. Completed in 30 March 2017.
1 March 2016
Quick facts
| Lead sponsor | Medical University of Lublin |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 2 June 2014 |
| Primary completion | 1 March 2016 |
| Estimated completion | 30 March 2017 |
Drugs / interventions tested
- Ologen
- Phacotrabeculectomy
- Mitomycin C — full drug profile →
Conditions studied
- Glaucoma — all drugs for Glaucoma →
- Cataract — all drugs for Cataract →
- Wound Heal — all drugs for Wound Heal →
Sponsor
Medical University of Lublin
Who can join
18 and older, any sex, with Glaucoma or Cataract. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy. 2. Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. 3. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03506542
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ologen
Trials testing the same drug.
- NCT02990143 — The Effectiveness of Ologen® Collagen Matrix in Preventing Intraocular Pressure (IOP) Spikes After Ahmed Glaucoma Valve · Phase 2 · terminated
Other recruiting trials for Glaucoma
Currently open trials in the same condition.
- NCT07455786 — Modified Trabeculectomy After Failure of Combined Phaco With GATT · NA · recruiting
- NCT07298356 — Automated Applanation Tonometry - Updated · NA · recruiting
- NCT07217678 — Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use · Phase 4 · recruiting
- NCT07145073 — Repetitive Transcranial Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies · NA · recruiting
- NCT07209410 — Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanopro · Phase 4 · recruiting
Other Medical University of Lublin trials
Trials by the same sponsor.
- NCT07085286 — Perfusion Related Evaluation of Systemic and Renal Vulnerability to Events in CABG · not yet recruiting
- NCT06897436 — Characterization of Immune Cells and Their Secreted Cytokines in Endometriosis Patients · not yet recruiting
- NCT06516835 — Diluted and Undiluted Enteral Nutrition · NA · not yet recruiting
- NCT07182318 — Validation of the FIGO Nutrition Checklist in Pregnant Women · completed
- NCT06282666 — Lumbar ESPB in Hip Replacement Surgery · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03506542 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Lublin
- Last refreshed: 25 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03506542.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing