Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension

NCT06152861
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Phase
Phase 2
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Recruitment status
Unknown
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Participants
250
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Lead sponsor
Glaukos Corporation
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Start date
2023-11-15
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Number of sites
1
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Summary
The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.
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Short title
Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension
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Official title
Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 2
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Study type
Interventional
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Completion date
2024-08-01
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First posted
2023-12-01
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Registry last updated
2023-12-06
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Primary completion date
2024-08-01
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Start date
2023-11-15
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Participants
250
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Participant count basis
Estimated
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Planned participants
250
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Glaukos Corporation
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06152861
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ClinicalTrials.gov ID
NCT06152861
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
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  1. change from baseline in mean diurnal IOP in the study eye

    Timeframe: Day 29

    Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Male or female, 18 years of age or older at the Screening Visit;
  • Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
  • Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
  • Qualifying IOP in the study eye;
  • Best-corrected visual acuity of approximately 20/80 Snellen in each eye

  • Sensitivity or allergy to travoprost or timolol;
  • Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
  • History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
  • History of cerebrovascular insufficiency;
  • Any form of glaucoma other than open-angle glaucoma
  • Advanced visual field loss or cup-to-disc ratio of 0.8 or greater
  • Non-qualifying prior surgeries or procedures in either eye
Sources for eligibility
clinicaltrials.gov

  • Glaukos Clinical Study SiteNewport Beach, United StatesRecruiting
Sources for sites
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Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (3)