Phase 2
Completed N=210
Performance of the Travoprost Intraocular Implant
Glaucoma, Open-Angle · Hypertension
Source: ClinicalTrials.gov NCT06582732 ↗
Enrolled (actual)
210
Serious AEs
1.0%
Results posted
Oct 2024
Primary outcomePrimary: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration — 5.57 ng/mL
Summary
To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid at specified timepoints post administration through 24 months
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration |
5.57 | — |
| PRIMARY Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration |
4.98 | — |
| PRIMARY Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration |
3.74 | — |
| PRIMARY Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration |
3.35 | — |
| PRIMARY Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration |
3.80 | — |
| PRIMARY Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration |
2.22 | — |
| PRIMARY Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration |
2.03 | — |
| SECONDARY Percent Residual Travoprost in Explanted Implant 12 Months Post-administration |
50.2 | — |
| SECONDARY Percent Residual Travoprost in Explanted Implant 3 Months Post-administration |
78.8 | — |
| SECONDARY Percent Residual Travoprost in Explanted Implant 6 Months Post-administration |
69.8 | — |
| SECONDARY Percent Residual Travoprost in Explanted Implant 24 Months Post-administration |
16.3 | — |
| SECONDARY Percent Residual Travoprost in Explanted Implant 21 Months Post-administration |
28.0 | — |
| SECONDARY Percent Residual Travoprost in Explanted Implant 18 Months Post-administration |
34.8 | — |
| SECONDARY Percent Residual Travoprost in Explanted Implant 15 Months Post-administration |
38.6 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson
- Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam.
- Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye.
- Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site
Exclusion Criteria
- Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
- Active ocular inflammation, infection or edema
- Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata
Data sourced from ClinicalTrials.gov (NCT06582732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.