Phase 2
Completed N=33
Study of Exchange of Travoprost Intraocular Implant
Source: ClinicalTrials.gov NCT04615403 ↗Enrolled (actual)
33
Serious AEs
6.1%
Results posted
Sep 2023
Primary outcomePrimary: Ocular Safety — 13 subjects
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Safety |
13 | — |
Eligibility Criteria
Inclusion Criteria
- Able and willing to attend scheduled follow-up exams for the duration of the study
- Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
- Best spectacle corrected visual acuity of 20/80 or better in each eye.
- Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.
Exclusion Criteria
- Glaucoma status as follows:
- Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
- Corneal status as follows:
- Any active inflammation or edema
- Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
- Implantation of Travoprost Intraocular Implant
- Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
- Fellow eye status as follows:
- Fellow eye actively enrolled in this trial or any other clinical trial
- Subject status as follows:
- Pregnant or planning to become pregnant during the course of the study
Data sourced from ClinicalTrials.gov (NCT04615403). 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.