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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896180
• Other study ID #: ALZ-1101-101
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2013
• Last updated: September 29, 2014
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: Alleanza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

11. History of herpes simplex keratitis.

12. Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.

13. 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).

14. 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).

15. Angle closure or occludable angles (Shaffer gonioscopic grade of < 3).

16. Cataract that compromises visualization of the fundus.

17. Cup-to-disc (C/D) ratio of > 0.8.

18. Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).

19. Pregnancy or lactation.

20. Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline directed therapy).

21. Allergy to prostaglandin analogues or carbonic anhydrase inhibitors.

22. Allergy to benzalkonium chloride.

23. History of moderate or severe renal or hepatic impairment.

24. Participation in any study of an investigational product within 30 days prior to Visit 1 or at any time during the study period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elevated Intraocular Pressure
• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• ALZ-1101
ALZ-1101 Ophthalmic Solution
• Latanoprost
Latanoprost 0.005% Ophthalmic Solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alleanza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goldmann applanation tonometry	Between-group comparison of the mean IOP values at the 10 AM time point at Visit 5 (Day 28).	28 days	No
Secondary	Goldmann applanation tonometry	Between-group comparison of the mean change from baseline in IOP at all time points at all post-baseline visits	28 days	No
Secondary	Goldmann applanation tonometry	Between-group comparison of the mean change from baseline in diurnal IOP at all post baseline visits	28 days	No
Secondary	Goldmann applanation tonometry	The proportion of subjects with IOP = 18 mm Hg at all time points at all post-baseline visits	28 days	No
Secondary	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.	28 days	Yes