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Completed

NCT Number: NCT05505292

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

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).

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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

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

New York, 10036, United States

Who can participate

Healthy volunteers accepted: No

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

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 (Contact Lens Dry Eye Questionnaire-8) 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.

Treatment and study plan

Lifitegrast 5% Ophthalmic Solution

Drug

Dosed twice a day for 8 weeks

Other names: Xiidra

Lifitegrast Ophthalmic Solution Vehicle

Other

Dosed twice a day for 8 weeks

Primary outcomes

  1. Efficacy of Lifitegrast Ophthalmic Solution 5% in Treating the Symptoms of Dry Eye in Contact Lens Wearers as Measured by Change in Total CLDEQ-8 Score From Baseline to Week 8

    Time frame: 8 weeks

    Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 8. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 8 than baseline).

Secondary outcomes

  1. Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks

    Time frame: 2 weeks

    Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 2. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 2 than baseline).

  2. Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks

    Time frame: 4 weeks

    Measured by change in total score on the CLDEQ-8 (Contact Lens Dry Eye Questionnaire) in subjects using lifitegrast ophthalmic solution as compared to subjects using lifitegrast ophthalmic solution vehicle from baseline to week 4. The CLDEQ-8 (Contact Lens Dry Eye Questionnaire) is a symptom questionnaire that assesses discomfort related to dry eye in contact lens wearers. The minimum possible CLDEQ-8 score is 0. The maximum possible CLDEQ-8 score is 37. Therefore, the maximum change is +/- 37. A negative change is an improvement in symptoms (a lower score at week 4 than baseline).

  3. Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8

    Time frame: 8 weeks

    Change in tear osmolarity (as measured by the TearLab device) from baseline to week 8 in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle.

    Measured in mOsm/L. A negative change is a lower osmolarity at week 8, which would be an improvement.

  4. Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8

    Time frame: 8 weeks

    Change in tear osmolarity (as measured by the TearLab device) from baseline to week 8 in the lifitegrast 5% group compared to subjects using lifitegrast ophthalmic solution vehicle.

    Measured in mOsm/L. A negative change is a lower osmolarity at week 8, which would be an improvement.

  5. Forced Choice Questionnaire

    Time frame: 8 weeks

    Forced choice questionnaire asking if the participant felt that their symptoms improved to the point that they would continue treatment outside of the study

  6. Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8

    Time frame: 8 weeks

    Measured by change in score for each Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) question in subjects using lifitegrast ophthalmic solution compared to subjects using lifitegrast ophthalmic solution vehicle.

    A negative change for a question from baseline to week 8 is an improvement in symptom frequency or intensity. Questions are for the past 2 weeks.

    Questions 1a, 2a, 3a & 4 ask about frequency of eye discomfort when wearing contacts, eye dryness, changeable, blurry vision in contacts and wanting to close your eyes. Scale: 0=Never, 1=Rarely, 2=Sometimes, 3=Frequently, 4=Constantly Questions 1b, 2b & 3b ask about the intensity of symptoms at the end of contact lens wearing time noted for questions 1a, 2a and 3a. Scale: 0-5, 0=Never have it, 5=Very Intense Question 5 asks how often did your eyes bother you so much that you felt you needed to take out your contact lenses. Scale: 1=Never, 2=Less than once a week, 3=Weekly, 4=Several times a week, 5=Daily, 6=Several times a day

Sponsors and collaborators

Lead sponsor

State University of New York College of Optometry

Other

Collaborators

  • Bausch & Lomb Incorporated
  • Novartis Pharmaceuticals

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Jan 14, 2025

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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