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

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Glaukos

Status and phase

Active, not recruiting
Phase 3

Conditions

Ocular Hypertension
Glaucoma, Open-Angle

Treatments

Combination Product: G2-TR intraocular implant containing travoprost
Drug: Sham surgery + active-comparator eye drops

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519386
GC-010

Details and patient eligibility

About

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).

Full description

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR 063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Enrollment

590 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

590 participants in 3 patient groups

Implant Group 1
Experimental group
Description:
G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Treatment:
Combination Product: G2-TR intraocular implant containing travoprost
Implant Group 2
Experimental group
Description:
G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Treatment:
Combination Product: G2-TR intraocular implant containing travoprost
Control Group
Active Comparator group
Description:
Sham surgery + active-comparator eye drops
Treatment:
Drug: Sham surgery + active-comparator eye drops

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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