Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug

February 10, 2016 updated by: Ocular Therapeutix, Inc.
The purpose of this study is to evaluate retention and replacement of the OTX Punctum Plug when placed in the canaliculus of the eyelid. Subjects will be followed for up to 1 year in order to assess retention and replacement of the OTX Punctum Plug for this duration. At the Day 90 visit, subjects will receive a second OTX Punctum Plug after removal of the initial OTX Punctum Plug. The subject will return for visits at Day 180, 270 and 360. On Days 180 and 270, the subject will again receive a new OTX Punctum Plug after the previous OTX Punctum Plug is removed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must be greater than or equal to 40 years of age.
  • Subject is in general good health with overall healthy eyes.
  • Subject has been informed of the nature of the study and is able to comply with study requirements, the visit schedule and has provided written informed consent, approved by the appropriate IRB.

Exclusion Criteria:

  • Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
  • History of ocular trauma within the past 6 months in either eye.
  • History of ocular infection (bacterial, viral, or fungal) or ocular inflammation within 3 months prior to the study in either eye.
  • History of chronic or recurrent inflammatory eye disease (i.e., iritis, scleritis, uveitis, herpes keratitis) in either eye.
  • History of clinically relevant or progressive retinal diseases such as retinal detachment, retinal degeneration, or diabetic retinopathy in either eye.
  • History of any other severe ocular pathology (including severe dry eye) in either eye.
  • History of any laser or incisional surgery within 6 weeks prior to the study or scheduled ocular surgery during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Formulation C
Two formulations of the OTX Punctum Plug will be evaluated in this trial. The difference in formulations is the time required for degradation of the PEG hydrogel. The persistence of OTX Punctum Plug (Formulation C) is anticipated to be slightly shorter than the persistence of OTX Punctum Plug (Formulation D).
Device: Punctum Plug
EXPERIMENTAL: Formulation D
Two formulations of the OTX Punctum Plug will be evaluated in this trial. The difference in formulations is the time required for degradation of the PEG hydrogel. The persistence of OTX Punctum Plug (Formulation C) is anticipated to be slightly shorter than the persistence of OTX Punctum Plug (Formulation D).
Device: Punctum Plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Punctum Plug retention for 90 days post insertion
Time Frame: 360 days
Retention of the first OTX Punctum Plug through Day 90, retention of the second OTX Punctum Plug through Day 180, retention of the third OTX Punctum Plug through Day 270, retention of the fourth OTX Punctum Plug through Day 360
360 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Successful insertion of a replacement OTX Punctum Plug at Days 90, 180 and 270
Time Frame: 270 days
270 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (ESTIMATE)

February 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • OTX-13-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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