Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers

NCT03431272 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: F49384759
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Discomfort with contact lens wear is the biggest reason why people stop wearing contact lenses. The investigators believe that inflammation is one of the causes of discomfort, and by blocking the inflammation using lifitegrast, the investigators may be able to relieve some of that discomfort. This study will enroll 50 subjects with contact lens discomfort and will receive lifitegrast to use over a period of approximately 3 months.

Conditions

Contact Lens Dry Eye

Keywords

contact lens, discomfort, dry eye

Outcome Measures

Primary Outcomes (1)

• Number of hours related to comfort in wearing contact lenses.

  The amount of comfortable lens wear time averaged over the 12th week of lens wear as reported with participant diary.

  Baseline to Week 12.

Secondary Outcomes (14)

• Number of hours related to comfort in wearing contact lenses.

  Baseline to Week 2.

• Number of hours related to comfort in wearing contact lenses.

  Baseline to Week 6.

• Number of hours related to total contact lens wear.

  Baseline to Week 2.

• Number of hours related to total contact lens wear.

  Baseline to Week 6.

• Number of hours related to total contact lens wear

  Baseline to Week 12

Study Arms (1)

Treatment

EXPERIMENTAL

lifitegrast ophthalmic solution 5.0%, to be instilled 1 drop in each eye, twice a day

Drug: Lifitegrast

Interventions

Lifitegrast DRUG

Eye drop

Also known as: Xiidra

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided informed consent.
• Age ≥ 18 years.
• Have a diagnosis of CLDE based on Contact Lens Dry Eye Questionnaire (CLDEQ) results:
• Answer to question #10 of "Yes" and score \>-0.13, or Answer to Question #10 of "No" and score \> 1.27, or Answer to #10 of "Unsure" and score \> 1.44
• Have a score of ≥ 2 on the Ocular Dryness Assessment at Visit 1.
• Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
• Are willing to avoid restricted medications for the time frames indicated during the study.
• Wears soft contact lenses at least 4 days a week for at least 5 hours per day using the same brand of contact lenses for at least the last 30 days.

You may not qualify if:

• Have a history of significant adverse reaction to lifitegrast or other components of the drug product, or contraindication to the use of lifitegrast or other components of the drug product.
• Have changed the brand or material or design of soft contact lenses or care solutions within 30 days prior to screening or anticipates the need to change current type/brand of contact lenses or care solutions throughout the 84-day study.
• Use contact lenses overnight.
• Use rigid gas permeable contact lenses or hybrid lenses.
• Have any uncontrolled systemic diseases that in the investigator's opinion could be expected to interfere with the study.
• Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
• Have any active ongoing ocular infection, ocular disease or condition that would require treatment with topical ophthalmic medications.
• Require any topically delivered ophthalmic medication for any condition during the study. This includes any preserved or unpreserved rewetting drops or artificial tears. The subject must not have used ophthalmic prescription medications for at least 30 continuous days prior to Visit 1, and must not have used rewetting drops or artificial tears for at least 5 continuous days prior to Visit 1.
• Have recently started taking omega-3 fatty acids supplements within the past 2 months.
• Are taking Omega-3 fatty acids supplements but unable to maintain consistent dosage for the duration of the study.
• Are unwilling or unable to comply with the protocol.
• Have been exposed to any investigational drug within the preceding 30 days.
• Are an employee of the site that is directly involved in the management, administration, or support of this study or be an immediate family member of the same.
• If female, participant must be non-pregnant and non-lactating, and those of childbearing potential must be using an acceptable method of birth control (i.e. an Intrauterine Contraceptive Device with failure rate of \<1%, hormonal contraceptives, or a barrier method.) If a female subject is abstinent, she must agree to use one of the acceptable contraceptive methods if she becomes sexually active.
• Have a clinically significant ophthalmic abnormality, infection, or disease noted by subject history or examination that would otherwise contraindicate contact lens wear and/or the use of lifitegrast (i.e., ≤ grade 3 giant papillary conjunctivitis, active ocular allergies, conjunctivitis, keratitis, uveitis).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Shire: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (8)

• Richdale K, Sinnott LT, Skadahl E, Nichols JJ. Frequency of and factors associated with contact lens dissatisfaction and discontinuation. Cornea. 2007 Feb;26(2):168-74. doi: 10.1097/01.ico.0000248382.32143.86.

  PMID: 17251807 BACKGROUND

• Efron N. Contact lens wear is intrinsically inflammatory. Clin Exp Optom. 2017 Jan;100(1):3-19. doi: 10.1111/cxo.12487. Epub 2016 Nov 2.

  PMID: 27806431 BACKGROUND

• Gao J, Morgan G, Tieu D, Schwalb TA, Luo JY, Wheeler LA, Stern ME. ICAM-1 expression predisposes ocular tissues to immune-based inflammation in dry eye patients and Sjogrens syndrome-like MRL/lpr mice. Exp Eye Res. 2004 Apr;78(4):823-35. doi: 10.1016/j.exer.2003.10.024.

  PMID: 15037117 BACKGROUND

• Zhang Y, Wang H. Integrin signalling and function in immune cells. Immunology. 2012 Apr;135(4):268-75. doi: 10.1111/j.1365-2567.2011.03549.x.

  PMID: 22211918 BACKGROUND

• Shire. Efficacy Info. 2017; https://www.xiidra-ecp.com/efficacy-symptom-improvement. Accessed 12/21/2017, 2017.

  BACKGROUND

• Shire. Xiidra and ICSS. 2017; https://www.xiidra-ecp.com/efficacy-treating-signs. Accessed 12/21/2017, 2017.

  BACKGROUND

• Shire. Mechanism of Action. 2017; https://www.xiidra-ecp.com/mechanism-of-action. Accessed 12/21/2017, 2017.

  BACKGROUND

• U.S. Food & Drug Administration. What is a Serious Adverse Event? 2016; https://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm. Accessed 12/11/2017, 2017.

  BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Jason J Nichols, OD PhD MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: October 25, 2018

Record last verified: 2018-10

Locations

US (1)