Sustained-release TimoD (timolol) implant placed during cataract surgery for glaucoma or ocular hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial enrolls small cohorts to examine safety and tolerability of three dose ranges of the TimoD sustained-release timolol implant. The implant is placed in one eye at the time of uncomplicated cataract surgery using an investigational injector system and is designed to release timolol slowly for up to one year. Three dose groups (low, intermediate, high) will each include six participants who receive a single implant and are followed for systemic timolol levels, intraocular pressure, and ocular safety including implant placement and removal. The primary focus is on detecting safety signals and tolerability, with any intraocular pressure effects recorded as secondary observations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Capable of giving signed informed consent.
* In good general and mental health without ongoing clinically significant abnormalities in medical history.
* Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement.
* Successful, uncomplicated cataract surgery

Exclusion Criteria:

* Subjects with a history of hypersensitivity or contraindications to β- blockers.
* Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure
* Significant risks caused by washout of ocular hypotensive medications.
* Clinically significant ocular pathology other than OHT, glaucoma and cataract.

Where it's running

• Panama Eye Center
  Panama City, Panama Recruiting

Study contacts

• Study coordinator: EyeD Pharma
• Email: dpo@eyedpharma.com
• Phone: +3242299000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.