Safety Study of Latanoprost Slow Release Insert

NCT01180062 | Terminated Phase 1 DMC

• 2 other identifiers: 10-0476-F1VIND# 109,182
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which will be conducted at one study site. This study will include 3 cohorts. Each cohort will have approximately 5 subjects. Subjects will not be randomized into the study. The first cohort will receive low dose drug insert, second cohort will receive 2 low dose drug inserts thus achieving twice the drug levels compared to cohort I and third cohort will receive high dose drug insert.

Conditions

Primary Open Angle Glaucoma (POAG); Ocular Hypertension (OHT)

Keywords

Latanoprost subconjunctival insert

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  1. Local reaction around the insert site including swelling, hyperemia, scarring, erosion, infection in the study eye 2. Hyperemia grading for both eyes 3. Discomfort and tolerability scale 4. Occurrence of iritis/uveitis in the study eye 5. Detection of macular thickening/edema in the study eye

  12 months

Secondary Outcomes (1)

• Intraocular pressure parameters i.e. mean IOP, IOP range, percentage reduction in IOP, IOP fluctuation.

  12 months

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Group 1 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 0.5µg Latanoprost.

Drug: Latanoprost

Active Comparator - Arm 2

ACTIVE COMPARATOR

Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost.

Drug: Latanoprost; Drug: Arm 2

Active Comparator - Arm 3

ACTIVE COMPARATOR

Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost.

Drug: Latanoprost; Drug: Latanoprost SR insert

Interventions

Latanoprost DRUG

Group 1 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 0.5µg Latanoprost. Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost. Duration of drug release is expected to be 3-6 months. Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost.

Also known as: Xalatan

Active Comparator - Arm 2; Active Comparator - Arm 3; Arm 1

Arm 2 DRUG

Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost.

Also known as: Xalatan

Active Comparator - Arm 2

Latanoprost SR insert DRUG

Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost.

Also known as: Xalatan

Active Comparator - Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female POAG and OHT subjects who are well controlled on mono therapy or dual therapy, who have not undergone any prior glaucoma surgeries and are not allergic or non-responders to any prostaglandin analogues, will be included in this study.
• At least 18 years old at time of consent.
• Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative glaucoma patients) or ocular hypertension in 1 or both eyes.
• IOP deemed as well controlled by investigators, with prostaglandin analogue/ prostanoid either as a monotherapy or part of dual medical therapy.
• Subjects with mild or moderate glaucoma where subjects can be without IOP lowering treatment for up to 2 months.
• Mean IOP of at least 22 mmHg in the study eye and not more than 36 mmHg in either eye at 8 AM on the baseline visit (after 4 weeks of washout).
• Mean IOP of at least 20 mmHg in the same eye that qualified at 8 AM and not more than 36 mmHg in either eye at 10 AM, 12 PM, 2 PM and 4 PM on baseline visit.
• Best Corrected Visual Acuity of 20/100 or better by Snellen's visual acuity measurement in each eye (or equivalent ETDRS Visual acuity).
• Clear ocular media with good view of optic disc and macula.
• Negative urine pregnancy test at baseline for women of childbearing potential.
• An informed consent document signed and dated by the subject or a legally acceptable representative.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

You may not qualify if:

• Closed/barely open anterior chamber angle or a history of acute angle closure (i.e., 75% of the circumference of the angle is 10° or less) in either eye.
• Subjects with diagnosis of secondary glaucoma.
• Diagnosis of a clinically significant or progressive retinal disease (e.g. diabetic retinopathy, macular degeneration) in either eye that would inhibit accurate VA testing.
• Advanced glaucoma defined by a cup/disc ratio \>0.8 or a history of severe central visual field loss in either eye.
• History of intolerance and or lack of response to prostaglandin analogues.
• History of hypersensitivity to latanoprost or any other ingredient in the study drug.
• Central corneal thickness greater than 600 μm in either eye.
• Any condition that prevents reliable applanation tonometry (e.g. significant abnormalities of the corneal surface) in either eye.
• History of severe dry eye.
• Eye lid abnormalities i.e. entropion, ectropion or lower lid retraction.
• Evidence of corneal punctate staining, exposure keratopathy or keratitis, history of infectious keratitis i.e. herpes.
• History of ocular cicatricial diseases i.e. cicatricial pemphigoid, pemphigus, S-J syndrome, conjunctival scarring secondary to topical medications.
• History of endothelial dystrophy (Fuchs, corneal guttata) or corneal edema.
• History of iritis or uveitis.
• History of clinically significant aspirin intolerant asthma (AIA).

Sponsors & Collaborators

• Daniel Moore: lead
• Pfizer: collaborator

Study Sites (1)

Univ of Ky Dept of Ophthalmology and Visual Sciences

Lexington, Kentucky, 40546, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost; DMAC2L protein, human

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Daniel B. Moore, M.D.

  Univ of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/PI

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

US (1)