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Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost

A Pilot, Single-Masked Study to Compare the Safety and Efficacy of ALZ-1101 (Latanoprost 0.005%/Dorzolamide 2.0%) to Latanoprost Ophthalmic Solution, 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension With Intraocular Pressure Inadequately Controlled By Latanoprost

NCT01896180•Alleanza Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a pilot, proof of concept study to evaluate the safety and efficacy of ALZ-1101 dosed once daily for 28 days compared to latanoprost 0.005% ophthalmic solution in patients with elevated intraocular pressure not adequately controlled with latanoprost.

Detailed Description

This is an exploratory, pilot, proof of concept Phase 2 study. The objectives include the comparison of efficacy of ALZ-1101 to latanoprost 0.005% ophthalmic solution in reducing elevated intraocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension who have IOP not adequately controlled with latanoprost. 70 Subjects (35 per arm) will be treated once daily (QD) in the evening with either ALZ-1101 or latanoprost for 28 days. Efficacy will be assessed at 3 separate times (8 AM, 10 AM and 4 PM) on each treatment visit (Days 0, 7, 14 and 28) by Goldmann applanation tonometry. Safety assessments will include slit lamp examination/anterior chamber cell and flare grading, ophthalmoscopy/fundus examination, visual acuity, visual field testing and colelction of adverse events. Subject rating of study medication comfort will be collected at each visit. Primary efficacy endpoint is the between-group comparison of the mean IOP at the 10 am time point at visit 5 (Day 28). Secondary endpoints include the between-group comparisons of the mean change from baseline in IOP at all time-points, between group comparison of the mean change from baseline in diurnal IOP at all post-baseline visits and the proportion of subjects with IOP ≤ 18 mm Hg at all time points at all post-baseline visits.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years or older.
•2. Primary open-angle glaucoma or OH on treatment with latanoprost 0.005% QD.
•3. At least one eye with IOP \> 18 mm Hg but ≤ 28 mm Hg at all time points (8 AM, 10 AM, and 4 PM) while on latanoprost monotherapy QD at Screening and Baseline (Day 0) visits. Measurements will be taken each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes), with AM measurements of IOP at least 2 hours apart. Screening must be at least one week before but within 2 weeks prior to Baseline.
•4. On latanoprost 0.005% QD for at least 4 weeks prior to randomization.
•5. Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.
•6. Stable corrected Snellen visual acuity (VA) better than 20/200 in the study eye.
•7. Central corneal thickness between 480-620 μm in the study eye.
•8. Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
•9. Provide signed written consent prior to participation in any study-related procedures.

Exclusion Criteria

•1. A mean deviation of \< -20 dB on visual field (VF) assessment.
•2. Presence of a scotoma within 5°of fixation on VF.
•3. Aphakia.
•4. Use of any antiglaucoma medication in addition to latanoprost QD within 2 weeks prior to Visit 1 or during the study period.
•5. Use of any topical ophthalmic steroid or nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Visit 1 or during the study period.
•6. Use of systemic carbonic anhydrase inhibitor within 2 weeks prior to Visit 1 or during the study period.
•7. Ocular surgery or ocular laser treatment of any kind within 3 months prior to Visit 1 or during the study period.
•8. Any history of glaucoma surgery (laser or non-laser).
•9. History of ocular allergy/inflammation and/or severe blepharitis and/or uveitis. Seasonal allergic conjunctivitis is acceptable (avoid enrollment of subjects who may experience seasonal flare-up during the study period). Mild blepharitis/blepharoconjunctivitis, typically associated with prostaglandin usage, is acceptable.
•10. History of ocular trauma or ocular infection within 3 months of Visit 1.
+14 more criteria

Locations (1)

Morrow, Georgia, United States

Key Dates

Start Date

July 1, 2013

Primary Completion Date

January 1, 2014

Completion Date

January 1, 2014

Last Updated

September 30, 2014

Enrollment

ACTUAL participants

Conditions

Primary Open Angle GlaucomaOcular HypertensionElevated Intraocular Pressure

Interventions

ALZ-1101

DRUG

Latanoprost

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost

Inclusion Criteria

Exclusion Criteria

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