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Safety Study of Latanoprost Slow Release Insert

NCT01180062 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-12-08

No results posted yet for this study

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)

Interventions

DRUG

Latanoprost

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.

DRUG

Arm 2

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

DRUG

Latanoprost SR insert

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Daniel Moore

    lead OTHER

Principal Investigators

  • Daniel B. Moore, M.D. · Univ of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01180062 on ClinicalTrials.gov