Overview

This trial is active, not recruiting.

Condition healthy subjects
Treatment punctum plug
Phase phase 1
Sponsor Ocular Therapeutix, Inc.
Start date February 2013
End date December 2016
Trial size 60 participants
Trial identifier NCT01800175, OTX-13-001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
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).
punctum plug
(Experimental)
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).
punctum plug

Primary Outcomes

Measure
Punctum Plug retention for 90 days post insertion
time frame: 360 days

Secondary Outcomes

Measure
Successful insertion of a replacement OTX Punctum Plug at Days 90, 180 and 270
time frame: 270 days

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Ocular Therapeutix, Inc..