Primary Open Angle GlaucomaPhase 2NCT01896180
Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost
A Phase 2 study testing ALZ-1101 and Latanoprost in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Alleanza Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension, Elevated Intraocular Pressure
- What is being tested?
- ALZ-1101 and Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Primary open-angle glaucoma or OH on treatment with latanoprost 0.005% QD.
- 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.
- On latanoprost 0.005% QD for at least 4 weeks prior to randomization.
- Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.
- Stable corrected Snellen visual acuity (VA) better than 20/200 in the study eye.
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- Central corneal thickness between 480-620 μm in the study eye.
- 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.
- Provide signed written consent prior to participation in any study-related procedures.
Who cannot join
- A mean deviation of < -20 dB on visual field (VF) assessment.
- Presence of a scotoma within 5°of fixation on VF.
- Aphakia.
- Use of any antiglaucoma medication in addition to latanoprost QD within 2 weeks prior to Visit 1 or during the study period.
- Use of any topical ophthalmic steroid or nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Visit 1 or during the study period.
- Use of systemic carbonic anhydrase inhibitor within 2 weeks prior to Visit 1 or during the study period.
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- Ocular surgery or ocular laser treatment of any kind within 3 months prior to Visit 1 or during the study period.
- Any history of glaucoma surgery (laser or non-laser).
- 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.
- History of ocular trauma or ocular infection within 3 months of Visit 1.
- History of herpes simplex keratitis.
- Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
- Severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial erosions of the cornea, and/or use of dry eye medication [including artificial tears] with a frequency exceeding 8 applications per day).
- Contact lens wear within one week prior to Visit 1 or during the study period (contact lens wear in an untreated fellow eye is allowed).
- Angle closure or occludable angles (Shaffer gonioscopic grade of < 3).
- Cataract that compromises visualization of the fundus.
- Cup-to-disc (C/D) ratio of > 0.8.
- Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
- Pregnancy or lactation.
- Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline directed therapy).
- Allergy to prostaglandin analogues or carbonic anhydrase inhibitors.
- Allergy to benzalkonium chloride.
- History of moderate or severe renal or hepatic impairment.
- Participation in any study of an investigational product within 30 days prior to Visit 1 or at any time during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- ALZ-1101, Latanoprost
- Keywords
- POAG, OHT, OHTN, IOP
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALZ-1101Drug
ALZ-1101 Ophthalmic Solution
LatanoprostDrug
Latanoprost 0.005% Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| ALZ-1101 | Experimental | ALZ-1101 ophthalmic solution dosed as 1 drop, once daily in the evening via topical ocular adminstration Receives: Drug: ALZ-1101 |
| Latanoprost | Active comparator | Latanoprost 0.005% ophthalmic solution dosed as 1 drop, once daily in the evening via topical ocular administration Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goldmann applanation tonometry
Between-group comparison of the mean IOP values at the 10 AM time point at Visit 5 (Day 28).
Measured: 28 days
Secondary outcomes (4)
Goldmann applanation tonometry
Between-group comparison of the mean change from baseline in IOP at all time points at all post-baseline visits
Measured: 28 days
Goldmann applanation tonometry
Between-group comparison of the mean change from baseline in diurnal IOP at all post baseline visits
Measured: 28 days
Goldmann applanation tonometry
The proportion of subjects with IOP ≤ 18 mm Hg at all time points at all post-baseline visits
Measured: 28 days
Safety
Assessment of the safety and tolerability will be assessed by slit lamp examination/anterior chamber cell and flare grading, ophthalmoscopy (cup-to-disc ratio)/dilated fundus examination, corrected Snellen visual acuity, VF testing, and adverse event assessment. Comfort data (subjective) will also be collected at each visit.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alleanza Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896180
- Sponsor's protocol ID
- ALZ-1101-101
- Status last verified
- Sep 2014
- First submitted
- 8 Jul 2013
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01896180
- Acronym / sponsor ID
- ALZ-1101-101
- Keywords
- POAG, OHT, OHTN, IOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Alleanza Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALZ-1101 | Experimental | Drug: ALZ-1101ALZ-1101 ophthalmic solution dosed as 1 drop, once daily in the evening via topical ocular adminstration |
| Latanoprost | Active comparator | Drug: LatanoprostLatanoprost 0.005% ophthalmic solution dosed as 1 drop, once daily in the evening via topical ocular administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older.
- Primary open-angle glaucoma or OH on treatment with latanoprost 0.005% QD.
- 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.
- On latanoprost 0.005% QD for at least 4 weeks prior to randomization.
- Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.
Key exclusion criteria (24 listed)
- A mean deviation of < -20 dB on visual field (VF) assessment.
- Presence of a scotoma within 5°of fixation on VF.
- Aphakia.
- Use of any antiglaucoma medication in addition to latanoprost QD within 2 weeks prior to Visit 1 or during the study period.
- Use of any topical ophthalmic steroid or nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Visit 1 or during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALZ-1101ALZ-1101 Ophthalmic Solution | Drug | ALZ-1101 |
| LatanoprostLatanoprost 0.005% Ophthalmic Solution | Drug | Latanoprost |
Primary outcome
Goldmann applanation tonometry
Time frame: 28 days
Between-group comparison of the mean IOP values at the 10 AM time point at Visit 5 (Day 28).
4 secondary outcomes
Goldmann applanation tonometry
Time frame: 28 days
Goldmann applanation tonometry
Time frame: 28 days
Goldmann applanation tonometry
Time frame: 28 days
Safety
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALZ-1101 and Latanoprost in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Alleanza Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goldmann applanation tonometry (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.