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Tear Osmolarity Changes in Habitual Contact Lens Wearers

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ClinicalTrials.gov Identifier: NCT03531346
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Wrocław University of Science and Technology
Information provided by (Responsible Party):
Izabela Garaszczuk, University of Valencia

Brief Summary:

Tear osmolarity refers to the amount of osmotically active particles in tears and has been reported as one of the best diagnostic test for dry eye disease. Our research focused on following changes in tear osmolarity and ocular symptoms in the time-course of one year after refitting habitual contact lens wearers or fitting novices with modern daily disposable soft contact lenses. Fifty-six contact lens wearers aged (mean ± standards deviation) 26 ± 4 y/o were refitted with Silicone-Hydrogel (Delefilcon A) or Hydrogel (Omafilcon A) lenses.

Study included seven visits: baseline measurement before the study, two visits for contact lens fit and control and follow-up measurements after three, six, and 12 months of contact lens wear followed by measurements on bare eye according to the baseline scheme (post-study visit).

An impedance-based osmometer was used to collect samples from the lower tear meniscus. A standard Ocular Surface Disease Index (OSDI) questionnaire was used to monitor subject-reported ocular symptoms. Statistically significant differences were noted in tear osmolarity in the time course of the study for both eyes.

An improvement in tear osmolarity was most prevalent among subjects with high initial tear osmolarity. Low osmolarity levels were maintained after the study.

The findings of this prospective study will reveal that habitual contact lens wearers or novices may benefit from refitting with modern daily disposable soft contact lenses.


Condition or disease Intervention/treatment Phase
Tear Film Hyperosmolarity Other: Daily-disposable soft contact lens Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Subjects were masked with respect to the lens type.
Primary Purpose: Other
Official Title: A 12-month Prospective Study of Tear Osmolarity in Contact Lens Wearers Refitted With Daily Disposable Soft Contact Lenses
Actual Study Start Date : October 6, 2016
Actual Primary Completion Date : December 16, 2016
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Tears

Arm Intervention/treatment
Experimental: Hyperosmolarity group
Healthy, young, habitual contact lens wearers with initial increased tear osmolarity (hyperosmolarity)
Other: Daily-disposable soft contact lens
Subjects were refitted with Silicone-Hydrogel (Delefilcon A) or Hydrogel (Omafilcon A) daily-disposable soft contact lenses based on their fit, reported comfort and tear film surface quality.

Experimental: Normal osmolarity
Healthy, young, habitual contact lens wearers with initial tear osmolarity reported as normal
Other: Daily-disposable soft contact lens
Subjects were refitted with Silicone-Hydrogel (Delefilcon A) or Hydrogel (Omafilcon A) daily-disposable soft contact lenses based on their fit, reported comfort and tear film surface quality.




Primary Outcome Measures :
  1. Tear film osmolarity [ Time Frame: 3 months ]
    Tear film osmolarity measured after 3-months of wearing newly-fitted contact lenses



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The refractive error limited to ±5.00 spherical and ±0.75 cylindrical diopters
  • Subjects with up-to-date optical prescription

Exclusion Criteria:

  • Signs and symptoms of severe eye dryness or inflammation
  • Substantial tear flow impairment
  • Any systemic or ocular disorder known to compromise the ocular surface or tear film quality.
  • At least two out of the following signs of dry eye disease:

    • Ocular Surface Disease Index higher or equal to 23,
    • Conjunctival staining higher or equal to 2 or/and corneal staining higher or equal to 2 (graded with Efron grading scale)
    • Fluorescein tear film break-up time shorter than 7 seconds.

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Responsible Party: Izabela Garaszczuk, Principal Investigator, Researcher, Optometrist, University of Valencia
ClinicalTrials.gov Identifier: NCT03531346     History of Changes
Other Study ID Numbers: 642760
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Izabela Garaszczuk, University of Valencia:
Tear film
Tear osmolarity
Contact lenses
Additional relevant MeSH terms:
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Lacerations
Rupture
Wounds and Injuries