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Completed

NCT Number: NCT01684436

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

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

punctal plug

Device

Punctal plugs inserted into the study eye on Day 1.

Primary outcomes

  1. Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye

    Time frame: Week 0 (Baseline)

    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.

  2. Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye

    Time frame: Week 3

    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 outcomes

  1. Corneal Fluorescein Staining Score in the Study Eye

    Time frame: Week 0 (Baseline), Week 3

    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.

  2. Tear Film Break-up Time (TBUT)

    Time frame: Week 0 (Baseline), Week 3

    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.

  3. Schirmer's Test Score

    Time frame: Week 0 (Baseline), Week 3

    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.

  4. Dry Eye Questionnaire Irritation Score

    Time frame: Week 0 (Baseline), Week 3

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 13, 2012
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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