Back to resultsThe Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study (CLEAR)
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lifitegrast 5% Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
Inclusion Criteria:
- Central or inferior corneal fluorescein staining defined by the Oxford Scale
- Reduced tear break up time (TBUT) ≤ 10 seconds.
- Able to comprehend and sign a statement of informed consent.
- Willing and able to complete all required postoperative visits.
Exclusion Criteria:
- Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure performed in the study eye within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
- Clinically significant ocular trauma.
- Active ocular Herpes simplex or Herpes Zoster infection
- Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) that is active, at the discretion of the investigator.
- Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye), at the discretion of the investigator.
- Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings, in the opinion of the investigator.
- Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis that would interfere with study findings, in the opinion of the investigator.
- Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that would interfere with study findings, in the opinion of the investigator.
- Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
- Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
Sites / Locations
- Harvard Eye Associates
- Bowden Eye & Associates
- Cleveland Eye Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single /arm
Arm Description
All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days.
Outcomes
Primary Outcome Measures
Change in corneal higher order aberrations
Change in corneal higher order aberrations after 7, 14, and 28 days of treatment.
Secondary Outcome Measures
Change in OSI after 7, 14, and 28 days of treatment.
Change in OSI after 7, 14, and 28 days of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04669561
Brief Title
The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study
Acronym
CLEAR
Official Title
The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study: An Investigation on Lifitegrast's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Insight LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients with dry eye, defined as corneal staining and a reduced tear breakup time, lifitegrast will improve higher order aberrations, ocular scatter index, corneal staining, and TBUT as soon as 1 week after initiating treatment.
Detailed Description
This is a multicenter, prospective, open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This is a multicenter, prospective, open label, self-controlled, single group study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single /arm
Arm Type
Experimental
Arm Description
All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days.
Intervention Type
Drug
Intervention Name(s)
Lifitegrast 5% Ophthalmic Solution
Intervention Description
Open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days.
Primary Outcome Measure Information:
Title
Change in corneal higher order aberrations
Description
Change in corneal higher order aberrations after 7, 14, and 28 days of treatment.
Time Frame
After 7, 14, and 28 days of treatment.
Secondary Outcome Measure Information:
Title
Change in OSI after 7, 14, and 28 days of treatment.
Description
Change in OSI after 7, 14, and 28 days of treatment.
Time Frame
After 7, 14, and 28 days of treatment.
Other Pre-specified Outcome Measures:
Title
Change in best corrected visual acuity after 7, 14, and 28 days of treatment.
Description
Change in best corrected visual acuity after 7, 14, and 28 days of treatment.
Time Frame
After 7, 14, and 28 days of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Central or inferior corneal fluorescein staining defined by the Oxford Scale
Reduced tear break up time (TBUT) ≤ 10 seconds.
Able to comprehend and sign a statement of informed consent.
Willing and able to complete all required postoperative visits.
Exclusion Criteria:
Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure performed in the study eye within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
Clinically significant ocular trauma.
Active ocular Herpes simplex or Herpes Zoster infection
Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) that is active, at the discretion of the investigator.
Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye), at the discretion of the investigator.
Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings, in the opinion of the investigator.
Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis that would interfere with study findings, in the opinion of the investigator.
Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that would interfere with study findings, in the opinion of the investigator.
Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hovanesian, MD
Organizational Affiliation
Research Insight LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Bowden Eye & Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with, the Sponsor, and such that confidential or proprietary information is not disclosed,
Learn more about this trial
The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study
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