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OpenTrials
Completed

NCT Number: NCT04024072

To Compare the Safety and Efficacy of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes

To compare the safety and efficacy of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

James D. Branch Ophthalmology

Winston-Salem, North Carolina, 27101, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes
  • Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
  • Adequate wash-out period prior to baseline of any ocular hypotensive medication.
  • Baseline (Day 0/hour 0) pressure ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of pressure between the eyes no greater than 5 mm Hg.
  • Baseline best corrected visual acuity equivalent to 20/200 or better in each eye

Exclusion criteria

  • Females who are pregnant, breast feeding, or planning a pregnancy.
  • Females of childbearing potential who do not agree to utilize an adequate form of contraception
  • Current, or past history of, severe hepatic or renal impairment
  • Current, or history within two months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye
  • Current corneal abnormalities that would prevent accurate readings with the Goldmann applanation tonometer
  • Functionally significant visual field loss
  • Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
  • Use at any time prior to baseline of an intraocular corticosteroid implant
  • Use within one week prior to baseline of contact lens
  • Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
  • Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy
  • Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
  • Having undergone within six months prior to baseline any other intraocular surgery (e.g., cataract surgery)
  • Having undergone within twelve months prior to baseline refractive surgery, filtering surgery, or laser surgery for pressure reduction

Treatment and study plan

Brinzolamide 1% ophthalmic suspension

Drug

Test product

Azopt 1% Ophthalmic Suspension

Drug

Reference product

Primary outcomes

  1. Mean Change in Intra-ocular Pressure

    Time frame: 6 weeks

    mean change in intra-ocular pressure of both eyes at four time points : at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits.

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Official study title

Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide Ophthalmic Suspension 1% to Azopt® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2019
Registry last updated
Mar 6, 2023

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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