Comparison of Intraocular Pressure (IOP)-Lowering Efficacy and Safety of AZORGA® Ophthalmic Suspension and COSOPT® Ophthalmic Solution

Last updated: October 13, 2016
Sponsor: Alcon, a Novartis Company
Overall Status: Completed

Phase

4

Condition

Williams Syndrome

Stress

Ocular Hypertension

Treatment

N/A

Clinical Study ID

NCT02325518
ALJ-P2014-1
UMIN000017569
  • Ages > 20
  • All Genders

Study Summary

The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Understand the nature of the study and sign informed consent.

  • Diagnosis of open angle glaucoma or ocular hypertension.

  • Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist atscreening visit, and allowed to instill only PGA for 4 weeks until the baseline visit.

  • Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit.

  • Other protocol-specified inclusion criteria may apply.

Exclusion

Exclusion Criteria:

  • History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonarydisease.

  • Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenicshock, right heart failure due to pulmonary hypertension or congestive heart failure.

  • History of hypersensitivity to any of the excipients of the study medications.

  • Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis,uncontrolled diabetes, or hepatic disorders.

  • Corneal disorder or history of chronic, recurrent or current severe inflammatory eyedisease in either eye.

  • History of ocular trauma in either eye within 6 months prior to the screeningexamination.

  • Ocular infection or ocular inflammation in either eye.

  • History of or current clinically significant or progressive retinal disease in eithereye.

  • Intraocular surgery in either eye within 6 months prior to the screening examination.

  • Ocular laser surgery in either eye within 3 months prior to the screening examination.

  • Any abnormality preventing reliable applanation tonometry of either eye.

  • Best-corrected visual acuity (BCVA) worse than 0.2 score (decimal visual acuity) ineither eye.

  • Severe visual field loss in either eye.

  • Use of prohibited medication, as specified in the protocol.

  • Pregnant, lactating, or intending to become pregnant during the study period.

  • Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination.

  • History of or current evidence of a severe illness or any other condition which wouldmake the subject, in the opinion of the investigator, unsuitable for the study.

  • Other protocol-specified exclusion criteria may apply.

Study Design

Total Participants: 218
Study Start date:
December 01, 2014
Estimated Completion Date:
December 31, 2015

Study Description

After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.

Connect with a study center

  • Contact Alcon Japan Ltd. for Trial Locations

    Tokyo, 107-0052
    Japan

    Site Not Available

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