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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00743249
First received: August 26, 2008
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Healthy
Dry Eye
Device: MINI MONOKA canalicular stent, 10 mm
Device: MINI MONOKA canalicular stent, 20 mm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Retention Time [ Time Frame: From baseline (Day 0) up to Month 3 ] [ Designated as safety issue: No ]
    At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.


Secondary Outcome Measures:
  • Percentage of Subjects Retaining the Stent at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.


Enrollment: 60
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Other Name: MINI MONOKA
Experimental: 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
Device: 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
Other Name: MINI MONOKA

Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743249

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa A Landry, Ph.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00743249     History of Changes
Other Study ID Numbers: C-07-23
Study First Received: August 26, 2008
Results First Received: February 22, 2013
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry eye
Tear duct
Punctal plug

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on July 20, 2014