Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers

Healthy Clinical Trial

Official title:

A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743249
• Other study ID #: C-07-23
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: April 3, 2013
• Start date: October 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months in subjects with or without dry eye.

Description:

This study consisted of 6 visits conducted over a period of 3 months. At Visit 1 (Day 0), the canalicular stent was inserted. If the stent insertion failed, the subject was rescheduled for insertion at the Day 2 visit. If the stent insertion was not successfully completed by the end of the Day 2 visit, the subject was discontinued from the study. Any subject who had the stent inserted but lost the stent (noticed or unnoticed) after the Day 2 Visit was considered to have completed the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Sign Informed Consent.

• With or without dry eye.

• Willing to discontinue contact lenses during the study.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Chronic, recurrent, or severe inflammatory eye disease.

• Ocular trauma within the past 6 months.

• Ocular hypertension or glaucoma.

• History of punctal plug/canalicular stent insertion.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Dry Eye
• Healthy

Intervention

Device:
• MINI MONOKA canalicular stent, 10 mm
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length
• MINI MONOKA canalicular stent, 20 mm
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Retention Time	At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.	From baseline (Day 0) up to Month 3	No
Secondary	Percentage of Subjects Retaining the Stent at Month 3	At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.	Month 3	No