Trial Outcomes & Findings for Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers (NCT NCT00743249)

NCT ID: NCT00743249

Last Updated: 2013-04-04

Results Overview

At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: From baseline (Day 0) up to Month 3
• Results posted on: 2013-04-04

Participant Flow

Subjects were recruited from four US study centers.

Participant milestones

Measure	Canalicular Stent, 10 mm MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months	Canalicular Stent, 20 mm MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
Overall Study STARTED	30	30
Overall Study COMPLETED	28	24
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Measure	Canalicular Stent, 10 mm MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months	Canalicular Stent, 20 mm MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
Overall Study Adverse Event	0	4
Overall Study Patient Decision Unrelated to Ad Event	0	1
Overall Study Unsuccessful insertion of stent	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Canalicular Stent, 10 mm n=28 Participants MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months	Canalicular Stent, 20 mm n=29 Participants MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months	Total n=57 Participants Total of all reporting groups
Age Continuous	63.0 years STANDARD_DEVIATION 10.5 • n=5 Participants	62.2 years STANDARD_DEVIATION 10.8 • n=7 Participants	62.6 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	29 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline (Day 0) up to Month 3

Population: Intent to treat

At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.

Outcome measures

Measure	Canalicular Stent, 10 mm n=28 Participants MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months	Canalicular Stent, 20 mm n=29 Participants MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
Mean Retention Time	87.4 Days Standard Deviation 16.8	61.9 Days Standard Deviation 36.0

SECONDARY outcome

Timeframe: Month 3

Population: Intent to treat

At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.

Outcome measures

Measure	Canalicular Stent, 10 mm n=28 Participants MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months	Canalicular Stent, 20 mm n=29 Participants MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
Percentage of Subjects Retaining the Stent at Month 3	92.9 Percentage of subjects	48.3 Percentage of subjects

Adverse Events

Canalicular Stent, 10 mm

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Canalicular Stent, 20 mm

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Canalicular Stent, 10 mm n=30 participants at risk MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months	Canalicular Stent, 20 mm n=30 participants at risk MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
Eye disorders Eyelids Pruritus	6.7% 2/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.	6.7% 2/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.
Eye disorders Foreign Body Sensation in Eyes	6.7% 2/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.	10.0% 3/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.
Eye disorders Eyelid Irritation	3.3% 1/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.	10.0% 3/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.
Eye disorders Eyelid Oedema	0.00% 0/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.	10.0% 3/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.
Eye disorders Lacrimation Increased	6.7% 2/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.	6.7% 2/30 • Adverse events were collected for the duration of the study (3 months, 26 days) The safety population includes all subjects randomized into the study for whom an attempt to insert a canalicular stent occurred.

Additional Information

Theresa A. Landry, Ph.D.

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER