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OpenTrials
Completed

NCT Number: NCT03850782

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consultorio Oftalmologico Dr. Fabian Lerner /ID# 235855, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.

Exclusion criteria

  • Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study.
  • Previous administration with Bimatoprost SR in the study eye.

Treatment and study plan

Bimatoprost (SR)

Drug

Study Eye: Cycles 1 - 3 administrations through the PRN treatment period.

Fellow Eye: Standard of care or Bimatoprost SR.

Primary outcomes

  1. Retreatment or rescue administered for IOP

    Time frame: Up to 48 months

    Treatment modality determined by investigator.

  2. Number of patients experiencing a treatment emergent adverse event

    Time frame: Baseline up to 48 months

    The number of patients who experienced one or more TEAE during the 48 month treatment period.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

Acronym: TRITON

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2019
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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