Dry EyePhase 4NCT05505292
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
A Phase 4 study testing Lifitegrast 5% Ophthalmic Solution in people with Dry Eye, run by State University of New York College of Optometry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Lifitegrast 5% Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2022to 15 May 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York College of Optometry Clinical Vision Research Center
New York, New York, 10036
About this study
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).
- Conditions
- Dry Eye
- Being tested
- Lifitegrast 5% Ophthalmic Solution, Lifitegrast Ophthalmic Solution Vehicle
- Keywords
- Dry Eye, Soft Contact Lenses
- 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.
Lifitegrast 5% Ophthalmic SolutionDrug
Also called Xiidra
Dosed twice a day for 8 weeks
Lifitegrast Ophthalmic Solution VehicleOther
Dosed twice a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Placebo comparator | Not described Receives: Other: Lifitegrast Ophthalmic Solution Vehicle |
| Lifitegrast Ophthalmic Solution 5% | Experimental | Not described Receives: Drug: Lifitegrast 5% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 8 weeks
Secondary outcomes (6)
Change in Total Score on the CLDEQ- 8 From Baseline to 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).
Measured: 2 weeks
Change in Total Score on the CLDEQ- 8 From Baseline to 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).
Measured: 4 weeks
Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8
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.
Measured: 8 weeks
Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8
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.
Measured: 8 weeks
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
Measured: 8 weeks
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start22 Sep 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York College of Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Danielle Iacono, State University of New York College of Optometry
- Investigators
- Danielle Iacono, OD, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505292
- Sponsor's protocol ID
- 1449068
- Status last verified
- Jan 2025
- First submitted
- 16 Aug 2022
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
- ClinicalTrials.gov ID
- NCT05505292
- Acronym / sponsor ID
- 1449068
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Soft Contact Lenses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- State University of New York College of OptometryUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, Bausch & Lomb Incorporated
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifitegrast Ophthalmic Solution Vehicle | Placebo comparator | Other: Lifitegrast Ophthalmic Solution Vehicle |
| Lifitegrast Ophthalmic Solution 5% | Experimental | Drug: Lifitegrast 5% Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Lifitegrast 5% Ophthalmic SolutionAlso: XiidraDosed twice a day for 8 weeks | Drug | Lifitegrast Ophthalmic Solution 5% |
| Lifitegrast Ophthalmic Solution VehicleDosed twice a day for 8 weeks | Other | Lifitegrast Ophthalmic Solution Vehicle |
Primary outcome
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).
6 secondary outcomes
Change in Total Score on the CLDEQ- 8 From Baseline to 2 Weeks
Time frame: 2 weeks
Change in Total Score on the CLDEQ- 8 From Baseline to 4 Weeks
Time frame: 4 weeks
Change in Tear Osmolarity OD (Right Eye) From Baseline to Week 8
Time frame: 8 weeks
Change in Tear Osmolarity OS (Left Eye) From Baseline to Week 8
Time frame: 8 weeks
Forced Choice Questionnaire
Time frame: 8 weeks
Change in Score for Each Question on the CLDEQ-8 From Baseline to Week 8
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Danielle Iacono, OD principal investigator
State University of New York College of Optometry
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 5% Ophthalmic Solution in people with Dry Eye, run by State University of New York College of Optometry 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 15 inclusion and 11 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: finished, as of the sponsor's last update on 14 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.