Phase 3
Completed N=590
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Glaucoma, Open-Angle · Hypertension
Source: ClinicalTrials.gov NCT03519386 ↗
Enrolled (actual)
590
Serious AEs
3.1%
Results posted
Sep 2023
Primary outcomePrimary: Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative — -8.40; -8.48; -7.69; -8.35 mmHg
◆ Published Evidence
Established
61citations · ~15 / year
Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications.
Summary
Phase III study to compare the safety and efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Linked Publications (4)
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Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications.
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Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial.
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Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials.
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Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative |
-8.40; -8.48; -7.69; -8.35; -8.44; -7.20 | — |
| SECONDARY Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with open-angle glaucoma or ocular hypertension.
- C/D ratio ≤ 0.8
- Zero to three preoperative ocular hypotensive medications
Exclusion Criteria
- Active corneal inflammation or edema.
- Retinal disorders not associated with glaucoma.
Data sourced from ClinicalTrials.gov (NCT03519386) and the linked publication. 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.