Contact Lens Dry EyePhase 4NCT03431272
Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers
A Phase 4 study testing Lifitegrast in people with Contact Lens Dry Eye, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Dry Eye
- What is being tested?
- Lifitegrast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Contact Lens Dry Eye
- Being tested
- Lifitegrast
- Keywords
- contact lens, discomfort, dry eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifitegrastDrug
Also called Xiidra
Eye drop
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | lifitegrast ophthalmic solution 5.0%, to be instilled 1 drop in each eye, twice a day Receives: Drug: Lifitegrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 12.
Secondary outcomes (14)
Number of hours related to comfort in wearing contact lenses.
The amount of comfortable lens wear time averaged over the 2nd week of lens wear as reported with participant diary.
Measured: Baseline to Week 2.
Number of hours related to comfort in wearing contact lenses.
The amount of comfortable lens wear time averaged over the 6th week of lens wear as reported with participant diary.
Measured: Baseline to Week 6.
Number of hours related to total contact lens wear.
The amount of total lens wear time averaged over the 2nd week of lens wear as reported with participant diary.
Measured: Baseline to Week 2.
Number of hours related to total contact lens wear.
The amount of total lens wear time averaged over the 6th week of lens wear as reported with participant diary.
Measured: Baseline to Week 6.
Number of hours related to total contact lens wear
The amount of total lens wear time averaged over the 12th week of lens wear as reported with participant diary.
Measured: Baseline to Week 12
Number of hours of overall eye dryness in the morning.
The amount of overall eye dryness experienced in the morning, averaged over the 2nd week of lens wear as reported with participant diary.
Measured: Baseline to Week 2.
Number of hours of overall eye dryness in the morning.
The amount of overall eye dryness experienced in the morning, averaged over the 6th week of lens wear as reported with participant diary.
Measured: Baseline to Week 6th.
Number of hours of overall eye dryness in the morning.
The amount of overall eye dryness experienced in the morning, averaged over the 12th week of lens wear as reported with participant diary.
Measured: Baseline to Week 12th.
Number of hours of overall eye dryness in the evening.
The amount of overall eye dryness experienced in the evening, averaged over the 2nd week of lens wear as reported with participant diary.
Measured: Baseline to Week 2.
Number of hours of overall eye dryness in the evening
The amount of overall eye dryness experienced in the evening, averaged over the 6th week of lens wear as reported with participant diary
Measured: Baseline to Week 6
Number of hours of overall eye dryness in the evening.
The amount of overall eye dryness experienced in the evening, averaged over the 12th week of lens wear as reported with participant diary.
Measured: Baseline to Week 12.
Change in Contact Lens Dry Eye diagnosis.
The participant diagnosis is made using the Contact Lens Dry Eye Questionnaire at Week 2.
Measured: Baseline to Week 2.
Change in Contact Lens Dry Eye diagnosis.
The participant diagnosis is made using the Contact Lens Dry Eye Questionnaire at Week 6.
Measured: Baseline to Week 6.
Change in Contact Lens Dry Eye diagnosis.
The participant diagnosis is made using the Contact Lens Dry Eye Questionnaire at Week 12.
Measured: Baseline to Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Nov 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: no longer interest / resources to start study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Contact Lens Dry EyeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Jason Nichols, University of Alabama at Birmingham
- Investigators
- Jason J Nichols, OD PhD MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431272
- Sponsor's protocol ID
- F49384759
- Status last verified
- Oct 2018
- First submitted
- 6 Feb 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17251807Efron 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.
PubMed 27806431Gao 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.
PubMed 15037117Zhang 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.
PubMed 22211918Shire. Efficacy Info. 2017; https://www.xiidra-ecp.com/efficacy-symptom-improvement. Accessed 12/21/2017, 2017.
Shire. Xiidra and ICSS. 2017; https://www.xiidra-ecp.com/efficacy-treating-signs. Accessed 12/21/2017, 2017.
Shire. Mechanism of Action. 2017; https://www.xiidra-ecp.com/mechanism-of-action. Accessed 12/21/2017, 2017.
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT03431272
- Acronym / sponsor ID
- F49384759
- Conditions
- Contact Lens Dry Eye
- Keywords
- contact lens, discomfort, dry eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no longer interest / resources to start study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Shire
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Lifitegrastlifitegrast ophthalmic solution 5.0%, to be instilled 1 drop in each eye, twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifitegrastAlso: XiidraEye drop | Drug | Treatment |
Primary outcome
Number of hours related to comfort in wearing contact lenses.
Time frame: Baseline to Week 12.
The amount of comfortable lens wear time averaged over the 12th week of lens wear as reported with participant diary.
14 secondary outcomes
Number of hours related to comfort in wearing contact lenses.
Time frame: Baseline to Week 2.
Number of hours related to comfort in wearing contact lenses.
Time frame: Baseline to Week 6.
Number of hours related to total contact lens wear.
Time frame: Baseline to Week 2.
Number of hours related to total contact lens wear.
Time frame: Baseline to Week 6.
Number of hours related to total contact lens wear
Time frame: Baseline to Week 12
Number of hours of overall eye dryness in the morning.
Time frame: Baseline to Week 2.
Number of hours of overall eye dryness in the morning.
Time frame: Baseline to Week 6th.
Number of hours of overall eye dryness in the morning.
Time frame: Baseline to Week 12th.
Number of hours of overall eye dryness in the evening.
Time frame: Baseline to Week 2.
Number of hours of overall eye dryness in the evening
Time frame: Baseline to Week 6
Number of hours of overall eye dryness in the evening.
Time frame: Baseline to Week 12.
Change in Contact Lens Dry Eye diagnosis.
Time frame: Baseline to Week 2.
Change in Contact Lens Dry Eye diagnosis.
Time frame: Baseline to Week 6.
Change in Contact Lens Dry Eye diagnosis.
Time frame: Baseline to Week 12.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 17251807Richdale 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.
- Background: PubMed 27806431Efron 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.
- Background: PubMed 15037117Gao 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.
- Background: PubMed 22211918Zhang 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.
- BackgroundShire. Efficacy Info. 2017; https://www.xiidra-ecp.com/efficacy-symptom-improvement. Accessed 12/21/2017, 2017.
- BackgroundShire. Xiidra and ICSS. 2017; https://www.xiidra-ecp.com/efficacy-treating-signs. Accessed 12/21/2017, 2017.
- BackgroundShire. Mechanism of Action. 2017; https://www.xiidra-ecp.com/mechanism-of-action. Accessed 12/21/2017, 2017.
- BackgroundU.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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason J Nichols, OD PhD MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lifitegrast in people with Contact Lens Dry Eye, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hours related to comfort in wearing contact lenses. (time frame: Baseline to Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431272, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.