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

Alcon

Status: Completed

Conditions: Healthy; Dry Eye

Treatments: Device: MINI MONOKA canalicular stent, 10 mm; Device: MINI MONOKA canalicular stent, 20 mm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00743249

C-07-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Canalicular stent, 10 mm

Experimental group

Description:

MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months

Treatment:

Device: MINI MONOKA canalicular stent, 10 mm

Canalicular stent, 20 mm

Experimental group

Description:

MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months

Treatment:

Device: MINI MONOKA canalicular stent, 20 mm