NCT03531346

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

May 8, 2018

Last Update Submit

May 18, 2018

Conditions

Tear Film Hyperosmolarity

Keywords

Tear filmTear osmolarityContact lenses

Outcome Measures

Primary Outcomes (1)

  • Tear film osmolarity

    Tear film osmolarity measured after 3-months of wearing newly-fitted contact lenses

    3 months

Study Arms (2)

Hyperosmolarity group

EXPERIMENTAL

Healthy, young, habitual contact lens wearers with initial increased tear osmolarity (hyperosmolarity)

Other: Daily-disposable soft contact lens

Normal osmolarity

EXPERIMENTAL

Healthy, young, habitual contact lens wearers with initial tear osmolarity reported as normal

Other: Daily-disposable soft contact lens

Interventions

Daily-disposable soft contact lensOTHER

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.

Hyperosmolarity groupNormal osmolarity

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Garaszczuk IK, Mousavi M, Szczesna-Iskander DH, Cervino A, Iskander DR. A 12-month Prospective Study of Tear Osmolarity in Contact Lens Wearers Refitted with Daily Disposable Soft Contact Lenses. Optom Vis Sci. 2020 Mar;97(3):178-185. doi: 10.1097/OPX.0000000000001488.

    PMID: 32168240DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Subjects were masked with respect to the lens type.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Researcher, Optometrist

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 21, 2018

Study Start

October 6, 2016

Primary Completion

December 16, 2016

Study Completion

December 7, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share