Phase 3 N=590 Randomized Double-blind Treatment

Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Glaucoma, Open-Angle · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT03519386 ↗

Enrolled (actual)

590

Serious AEs

3.1%

Results posted

Sep 2023

Primary outcome: 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 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: G2-TR intraocular implant containing travoprost (Combination_product); Sham surgery + active-comparator eye drops (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Glaukos Corporation
Primary completion: Apr 2022

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	—	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03519386). 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.