Clinical trial NCT03431272: Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers
Official title: Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Contact Lens Dry Eye
Keywords: contact lens, discomfort, dry eye
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2018-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The most common reason for contact lens drop out is ocular discomfort, with patients identifying dryness as the major reason. Currently, many patients with contact lens dry eye (CLDE) utilize rewetting drops to relieve their symptoms. The problem with rewetting drops is that they fail as they are transient, and do not address the inflammatory component of contact lens discomfort. Lifitegrast 5.0% ophthalmic solution was approved and is now marketed as Xiidra, for the treatment of signs and symptoms of dry eye disease. Lifitegrast works by reducing inflammation, which suggests that it may be effective in patients with contact lens dry eye. More specifically, lifitegrast may work by blocking the interaction between ICAM-1 and LFA-1, which leads to a decrease in the activation and recruitment of T-cells, and a decrease in pro-inflammatory cytokines.

The safety and efficacy of Xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients. Each study assessed the effects of Xiidra on symptoms using an Eye Dryness Score (EDS), which is a visual analogue ranging from 0 (no discomfort) to 100 (maximal discomfort). In two of those studies, lifitegrast was shown to improve symptom relief at weeks 2, 6, and 12 compared to the placebo (https://www.xiidra-ecp.com/efficacy-symptom-improvement).

Each of the four clinical trials mentioned above also assessed clinical signs of dry eye disease, with a particular focus on inferior corneal staining graded on 0.5 unit increments on a 0 (no staining) to 4 scale (coalescent). In three of the four clinical trials, lifitegrast reduced inferior corneal staining by week 12, compared to placebo (https://www.xiidra-ecp.com/efficacy-treating-signs).

Contact lens dry eye is mediated by significant symptoms of ocular surface dryness, in addition to similar clinical signs of dry eye disease such as corneal staining and inflammation. Thus, the purpose of this interventional study is to examine the effect of lifitegrast ophthalmic solution in subjects with contact lens dry eye.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Have had a history of corneal surgery (corneal transplants, LASIK, PRK).

Primary outcomes:
measure: Number of hours related to comfort in wearing contact lenses.
timeFrame: Baseline to Week 12.
Secondary outcomes:
measure: Number of hours related to comfort in wearing contact lenses.
timeFrame: Baseline to Week 2.
measure: Number of hours related to comfort in wearing contact lenses.
timeFrame: Baseline to Week 6.
measure: Number of hours related to total contact lens wear.
timeFrame: Baseline to Week 2.
measure: Number of hours related to total contact lens wear.
timeFrame: Baseline to Week 6.
measure: Number of hours related to total contact lens wear
timeFrame: Baseline to Week 12
measure: Number of hours of overall eye dryness in the morning.
timeFrame: Baseline to Week 2.
measure: Number of hours of overall eye dryness in the morning.
timeFrame: Baseline to Week 6th.
measure: Number of hours of overall eye dryness in the morning.
timeFrame: Baseline to Week 12th.
measure: Number of hours of overall eye dryness in the evening.
timeFrame: Baseline to Week 2.
measure: Number of hours of overall eye dryness in the evening
timeFrame: Baseline to Week 6
measure: Number of hours of overall eye dryness in the evening.
timeFrame: Baseline to Week 12.
measure: Change in Contact Lens Dry Eye diagnosis.
timeFrame: Baseline to Week 2.
measure: Change in Contact Lens Dry Eye diagnosis.
timeFrame: Baseline to Week 6.
measure: Change in Contact Lens Dry Eye diagnosis.
timeFrame: Baseline to Week 12.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jason J Nichols, OD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Shire. Efficacy Info. 2017; https://www.xiidra-ecp.com/efficacy-symptom-improvement. Accessed 12/21/2017, 2017.
citation: Shire. Xiidra and ICSS. 2017; https://www.xiidra-ecp.com/efficacy-treating-signs. Accessed 12/21/2017, 2017.
citation: Shire. Mechanism of Action. 2017; https://www.xiidra-ecp.com/mechanism-of-action. Accessed 12/21/2017, 2017.
citation: 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.