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

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01800175
• Other study ID #: OTX-13-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: February 25, 2013
• Last updated: February 10, 2016
• Start date: February 2013

Study information

• Verified date: February 2016
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• Punctum Plug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Punctum Plug retention for 90 days post insertion	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	Yes
Secondary	Successful insertion of a replacement OTX Punctum Plug at Days 90, 180 and 270		270 days	Yes