Ocular Safety
Primary
· 12 Months
Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye
| Group | Value | 95% CI |
|---|---|---|
| Implantation and Exchange | 13 |
Last reviewed · How we verify
NCT04615403
Study of Exchange of Travoprost Intraocular Implant
Completed
Phase 2
Results posted
Last updated 26 September 2023
What this trial tests
Phase 2 trial testing Travoprost in Open Angle Glaucoma in 33 participants. Completed in 28 February 2022.
Timeline
19 November 2020
Primary endpoint
28 February 2022
28 February 2022
28 February 2022
Quick facts
| Lead sponsor | Glaukos Corporation |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 19 November 2020 |
| Primary completion | 28 February 2022 |
| Estimated completion | 28 February 2022 |
| Sites | 14 locations across Philippines, United States |
Drugs / interventions tested
- Travoprost (TRAVOPROST) — full drug profile →
Conditions studied
- Open Angle Glaucoma — all drugs for Open Angle Glaucoma →
Sponsor
Glaukos Corporation — full company profile →
Who can join
18 and older, any sex, with Open Angle Glaucoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Implantation and Exchange
Serious: 2/33 (6%)
Deaths: 1/33
Serious adverse events (2 terms)
| Reaction | System | Implantation and Exchange |
|---|---|---|
| Death | General disorders | — |
| Retinal vein occlusion | Eye disorders | — |
Other adverse events (18 terms — click to expand)
| Reaction | System | Implantation and Exchange |
|---|---|---|
| Visual field defect | Nervous system disorders | — |
| Eye irritation | Eye disorders | — |
| Corona virus infection | Infections and infestations | — |
| Intraocular pressure increased | Investigations | — |
| Corneal pigmentation | Eye disorders | — |
| Diabetic retinopathy | Eye disorders | — |
| Iridodialysis | Eye disorders | — |
| Photophobia | Eye disorders | — |
| Posterior capsule opacification | Eye disorders | — |
| Retinal hemorrhage | Eye disorders | — |
| Hordeolum | Eye disorders | — |
| Conjunctivitis viral | Eye disorders | — |
| Corneal abrasion | Eye disorders | — |
| Ear infection | Infections and infestations | — |
| Gout | Metabolism and nutrition disorders | — |
| Atonic seizures | Nervous system disorders | — |
| Cerebral arteriosclerosis | Nervous system disorders | — |
| Trigeminal neuralgia | Nervous system disorders | — |
Most-reported serious reactions: Death, Retinal vein occlusion.
Data from ClinicalTrials.gov NCT04615403 adverse events section.
Sponsor's own description
The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension.
Berdahl JP, Sarkisian SR, Ang RE, Doan LV, et al · · 2024 · cited 21× · PMID 38060092 · DOI 10.1007/s40265-023-01973-7 -
Devices and Treatments to Address Low Adherence in Glaucoma Patients: A Narrative Review.
Cvenkel B, Kolko M. · · 2022 · cited 14× · PMID 36614952 · DOI 10.3390/jcm12010151 -
Safety and Feasibility of the Exchange Procedure for the Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension.
Berdahl JP, Lehmann RP, Jones JJ, Sarkisian SR, et al · · 2026 · PMID 41832303 · DOI 10.1007/s40123-026-01355-8
Verify or expand the search:
- PubMed search for NCT04615403
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Travoprost
Trials testing the same drug.
- NCT02914509 — Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT · Phase 3 · completed
Other recruiting trials for Open Angle Glaucoma
Currently open trials in the same condition.
- NCT07228221 — Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma · Phase 4 · recruiting
- NCT06883123 — Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost · Phase 4 · recruiting
- NCT06666855 — A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China · Phase 3 · active not recruiting
- NCT06246136 — Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery · NA · recruiting
- NCT06061718 — Travoprost Intraocular Implant in Conjunction With Cataract Surgery · Phase 3 · active not recruiting
Other Glaukos Corporation trials
Trials by the same sponsor.
- NCT06061718 — Travoprost Intraocular Implant in Conjunction With Cataract Surgery · Phase 3 · active not recruiting
- NCT05119920 — Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease · Phase 2 · completed
- NCT05124275 — Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia · Phase 2 · completed
- NCT05127551 — Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor · NA · active not recruiting
- NCT06582732 — Performance of the Travoprost Intraocular Implant · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04615403 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Glaukos Corporation
- Last refreshed: 26 September 2023
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/NCT04615403.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing