Status:

COMPLETED

Nictavi Tarsus Patch for Managing Lagophthalmos

Lead Sponsor:

Angeline Nguyen

Conditions:

Lagophthalmos

Eligibility:

All Genders

Up to 17 years

Phase:

NA

Brief Summary

Lagophthalmos is the inability to completely close the eyelids, which can be caused by conditions such as facial nerve dysfunction and eyelid scarring. Lagophthalmos causes evaporation of the tears, w...

Detailed Description

The investigators plan to recruit 20 children and adolescents (ages 0 to 17 years, inclusive) from the Children's Hospital Los Angeles (CHLA) ophthalmology clinics who have lagophthalmos affecting one...

Eligibility Criteria

Inclusion

  • Patient subjects:
  • Between 0 and 17 years old (inclusive)
  • Diagnosis of unilateral or bilateral lagophthalmos based upon an eye examination since Jan 1, 2019
  • Previously recommended to use an eyelid closure method (such as using medical tape, steristrips, moisture chambers, temporary tarsorrhaphy, etc).
  • English-speaking
  • Able to participate in an age-appropriate manner for the eye examination
  • Parent subjects:
  • 18 years or older
  • English-speaking

Exclusion

  • Patient subjects:
  • Presence of corneal abrasion or corneal ulcer on the study eye
  • Active use of bandage contact lens in the study eye
  • Active dermatitis affecting the eyelids
  • Inability to tolerate the Tarsus Patch in clinic
  • Inability for complete mechanical closure of the eyelid by any means
  • Allergy to adhesive
  • Parent subjects:
  • Prisoners

Key Trial Info

Start Date :

March 30 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2022

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05183282

Start Date

March 30 2022

End Date

December 1 2022

Last Update

July 21 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Children's Hospital Los angeles

Los Angeles, California, United States, 90027