Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01684436
First received: September 11, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

This study will access changes in tear protein levels and symptoms of dry eye following insertion of a punctal plug.


Condition Intervention Phase
Dry Eye
Device: Punctal Plug
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye [ Time Frame: Week 0 (Baseline) ] [ Designated as safety issue: No ]
    A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.

  • Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.


Secondary Outcome Measures:
  • Corneal Fluorescein Staining Score in the Study Eye [ Time Frame: Week 0 (Baseline), Week 3 ] [ Designated as safety issue: No ]
    The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition.

  • Tear Film Break-up Time (TBUT) [ Time Frame: Week 0 (Baseline), Week 3 ] [ Designated as safety issue: No ]
    TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film.

  • Schirmer's Test Score [ Time Frame: Week 0 (Baseline), Week 3 ] [ Designated as safety issue: No ]
    The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.

  • Dry Eye Questionnaire Irritation Score [ Time Frame: Week 0 (Baseline), Week 3 ] [ Designated as safety issue: No ]
    Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms.


Enrollment: 30
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Punctal plug
Punctal plugs inserted into the study eye on Day 1.
Device: Punctal Plug
Punctal plugs inserted into the study eye on Day 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with moderate to severe dry eye

Exclusion Criteria:

  • Previous punctal plug insertion in the last 3 months or presence of plugs at the time of study
  • Contact lens wear in the 7 days prior to study start or during the study
  • LASIK procedure in the last year
  • Cataract or other eye surgery in the last 3 months
  • Corneal grafts
  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: NCT01684436

Locations
Singapore
Singapore, Singapore
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01684436     History of Changes
Other Study ID Numbers: APMA-DE-0812
Study First Received: September 11, 2012
Results First Received: July 10, 2014
Last Updated: August 14, 2014
Health Authority: Singapore: Health Sciences Authority

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 September 29, 2014