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Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lifitegrast 5% Ophthalmic Solution
Lifitegrast Ophthalmic Solution Vehicle
Sponsored by
State University of New York College of Optometry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye, Soft Contact Lenses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects must read, understand and sign the Statement of Informed Consent
  2. Subjects must be at least 18 years of age
  3. Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule
  4. Habitual contact lenses must have a suitable fit as determined by the investigator
  5. Subjects must report a history of dry eye symptoms, for which they have used rewetting drops or Artificial Tears (ATs) in the past 30 days
  6. Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study
  7. Subjects must have a score of 12 or higher on the CLDEQ at baseline

  8. Subjects must have at least 2 of the following signs of dry eye disease:

    1. High tear osmolarity > 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes
    2. Any corneal staining
    3. Any bulbar conjunctival staining
    4. Low TBUT (tear break up time) (<10s)
    5. Schirmer <10mm in either eye
  9. Subjects must be able to read at least half of the 20/25 (via entrance Snellen visual acuity) or better in each eye in their current contact lens prescription.
  10. Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study.

Exclusion Criteria:

  1. Currently pregnant or breastfeeding by self-report
  2. Allergy to lifitegrast ophthalmic solution 5% (Xiidra)
  3. Habitual extended wear contact lens schedule
  4. Any active ocular disease that may affect the ocular surface other than dry eye (significant blepharitis, allergic conjunctivitis, lagophthalmos, chalazia, hordeolum etc.)
  5. Any meibomian gland dysfunction, blepharitis, corneal neovascularization or papillary conjunctivitis that is grade 3 or higher using the Efron Grading Scale.
  6. Excessive corneal staining, that in the opinion of the investigator, is a contraindication to contact lens use.
  7. History of ocular surgery
  8. Any active ocular infection
  9. Use of any topical ophthalmic medications other than artificial tears or rewetting drops
  10. Inability to perform necessary visual function assessments
  11. Punctal plug insertion in the last 3 months, or presence of punctal plugs at the time of the exam.

Sites / Locations

  • State University of New York College of Optometry Clinical Vision Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Lifitegrast Ophthalmic Solution Vehicle

Lifitegrast Ophthalmic Solution 5%

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in contact lens wearers
Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) as compared to subjects using lifitegrast ophthalmic solution vehicle

Secondary Outcome Measures

Change in tear osmolarity
Change in tear osmolarity at 8 weeks in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle
Forced choice questionnaire
Forced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study
Change in total score on the CLDEQ- 8 at 2 weeks and 4 weeks
Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle
Trends in responses to individual questions on the CLDEQ-8
Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle

Full Information

First Posted
August 16, 2022
Last Updated
August 10, 2023
Sponsor
State University of New York College of Optometry
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05505292
Brief Title
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
Official Title
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York College of Optometry
Collaborators
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. We hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye, Soft Contact Lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifitegrast Ophthalmic Solution Vehicle
Arm Type
Placebo Comparator
Arm Title
Lifitegrast Ophthalmic Solution 5%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lifitegrast 5% Ophthalmic Solution
Other Intervention Name(s)
Xiidra
Intervention Description
Dosed twice a day for 8 weeks
Intervention Type
Other
Intervention Name(s)
Lifitegrast Ophthalmic Solution Vehicle
Intervention Description
Dosed twice a day for 8 weeks
Primary Outcome Measure Information:
Title
Efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in contact lens wearers
Description
Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) as compared to subjects using lifitegrast ophthalmic solution vehicle
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in tear osmolarity
Description
Change in tear osmolarity at 8 weeks in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle
Time Frame
8 weeks
Title
Forced choice questionnaire
Description
Forced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study
Time Frame
8 weeks
Title
Change in total score on the CLDEQ- 8 at 2 weeks and 4 weeks
Description
Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle
Time Frame
2 weeks and 4 weeks
Title
Trends in responses to individual questions on the CLDEQ-8
Description
Measured by change in total score on the CLDEQ-8 in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle
Time Frame
2 weeks, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must read, understand and sign the Statement of Informed Consent Subjects must be at least 18 years of age Subjects must be habitual soft contact lens (CL) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule Habitual contact lenses must have a suitable fit as determined by the investigator Subjects must report a history of dry eye symptoms, for which they have used rewetting drops or Artificial Tears (ATs) in the past 30 days Subjects must be willing to discontinue the use of Artificial Tears (ATs) and rewetting drops for the duration of the study Subjects must have a score of 12 or higher on the CLDEQ at baseline Subjects must have at least 2 of the following signs of dry eye disease: High tear osmolarity > 308 mOsm/L, (milliosmoles per liter) or a difference greater than 8 mOsm/L between eyes Any corneal staining Any bulbar conjunctival staining Low TBUT (tear break up time) (<10s) Schirmer <10mm in either eye Subjects must be able to read at least half of the 20/25 (via entrance Snellen visual acuity) or better in each eye in their current contact lens prescription. Subjects currently wearing reusable contact lenses must be willing to use Clear Care solution for cleaning and disinfecting throughout the study. Exclusion Criteria: Currently pregnant or breastfeeding by self-report Allergy to lifitegrast ophthalmic solution 5% (Xiidra) Habitual extended wear contact lens schedule Any active ocular disease that may affect the ocular surface other than dry eye (significant blepharitis, allergic conjunctivitis, lagophthalmos, chalazia, hordeolum etc.) Any meibomian gland dysfunction, blepharitis, corneal neovascularization or papillary conjunctivitis that is grade 3 or higher using the Efron Grading Scale. Excessive corneal staining, that in the opinion of the investigator, is a contraindication to contact lens use. History of ocular surgery Any active ocular infection Use of any topical ophthalmic medications other than artificial tears or rewetting drops Inability to perform necessary visual function assessments Punctal plug insertion in the last 3 months, or presence of punctal plugs at the time of the exam.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Iacono, OD
Organizational Affiliation
State University of New York College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
State University of New York College of Optometry Clinical Vision Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States

12. IPD Sharing Statement

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Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

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