Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
Primary Purpose
Dry Eye, Contact Lens Complication
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
HydroEye®
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring HydroEye®, Contact Lens Discomfort, Dry Eye, Supplement
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Provide informed consent and authorization to disclose protected health information
- Willing to follow study protocol
- Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye
- Wear soft contact lenses as daily wear for at least 6 hours per day and at least 5 days per week for the past 30 days
- Have at least a 2-hour difference between overall wear time and comfortable wear time of contact lenses
- Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score ≥ 12)
- Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report
- Clinical assessment that contact lens material, fit, prescription, and care system are not reasons for contact lens discomfort
- Demonstrate at least 80% compliance in completion of daily electronic diary (submitted through Qualtrics Research Suite) between V1 and V2
- Willing to discontinue use of any current dry eye treatment (including use of commercial hygiene masks, and except for artificial tears) for 4 weeks before randomization and during the course of the 6-month study.
Exclusion Criteria:
- Meibomian gland dropout ≥75% in either eyelid
- Any changes to the contact lens material, fit, prescription, or care system in the 30 days preceding enrollment or anticipates needing to make changes during the course of the study
- Any systemic disease known to be associated with dry eye
- Any significant ocular surface abnormality that could be associated with ocular surface discomfort, such as ectropion, entropion, trichiasis, infection, severe allergic conjunctivitis, severe eyelid inflammation, etc.
- Any overnight wear of contact lenses or use of daily disposable contact lenses
- Any previous corneal surgery, including all types of corneorefractive surgery
- Have temporary and/or permanent punctal plugs inserted
- Use of supplemental fish oil, or seed oils from borage, evening primrose, sea buckthorn, flaxseed, or black currant within the last 60 days
- Routine, usual dietary intake of more than 8 oz. of cold-water fatty fish (tuna, salmon, mackerel, sea bass, sardines or herring) per week).
- Use of anticoagulant therapy or regular, daily use of aspirin, NSAIDs, or steroid medications within the past 30 days, or a history of easy bruising
- Allergy or intolerance to fish or any ingredients contained in the active or placebo formulas [See appendix or ingredient list]
- Participation in a clinical trial in the past 30 days
- Current pregnancy or breast feeding as indicated by self-report
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HydroEye®
Placebo
Arm Description
Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
Outcomes
Primary Outcome Measures
Contact Lens Dry Eye Questionnaire (CLDEQ-4)
The CLDEQ-4 is a contact lens specific symptoms survey, we are using the Rasch validated version; range = 0-18 with 18 being most symptomatic.
Secondary Outcome Measures
Tear LTB4 Levels
LTB4 values will be tested with a biochemical assay to estimate eye surface inflammation.
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic.
Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
NPSI is a pain specific symptoms survey; range = 0-100 with 100 being most symptomatic.
Tear Breakup Time
This is a measure of tear stability with higher values being better (seconds).
Schirmer I Test
This is a measure of tear volume with higher values being better (0 mm - 35 mm).
Corneal Staining
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 15).
Conjunctival Staining
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).
Full Information
NCT ID
NCT04163328
First Posted
November 12, 2019
Last Updated
August 16, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04163328
Brief Title
Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
Official Title
Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
HydroEye® is a dietary supplement that contains both EPA and DHA, as well as GLA and ALA in the form of black currant seed oil. It also has vitamins A, E, C, B6, and magnesium, many of which are involved in fatty acid metabolism. In 2013, Sheppard et al. tested HydroEye® in dry eye patients who were not contact lens wearers and found that symptoms and corneal smoothness improved in response to HydroEye® supplementation. To date, HydroEye® has not been assessed in patients with contact lens discomfort; therefore, the purpose of this clinical trial is to determine the efficacy of HydroEye® as a treatment for contact lens discomfort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Contact Lens Complication
Keywords
HydroEye®, Contact Lens Discomfort, Dry Eye, Supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The proposed research study is a randomized, double-masked, controlled clinical trial to test the efficacy of HydroEye® nutraceutical in subjects with contact lens discomfort.
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HydroEye®
Arm Type
Experimental
Arm Description
Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
Intervention Type
Drug
Intervention Name(s)
HydroEye®
Intervention Description
This is an omega-3 fatty acids supplement.
Primary Outcome Measure Information:
Title
Contact Lens Dry Eye Questionnaire (CLDEQ-4)
Description
The CLDEQ-4 is a contact lens specific symptoms survey, we are using the Rasch validated version; range = 0-18 with 18 being most symptomatic.
Time Frame
Mean change at 6 months.
Secondary Outcome Measure Information:
Title
Tear LTB4 Levels
Description
LTB4 values will be tested with a biochemical assay to estimate eye surface inflammation.
Time Frame
Mean change at 6 months.
Title
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
Description
The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic.
Time Frame
Mean change at 6 months.
Title
Neuropathic Pain Symptom Inventory (NPSI) Questionnaire
Description
NPSI is a pain specific symptoms survey; range = 0-100 with 100 being most symptomatic.
Time Frame
Mean change at 6 months.
Title
Tear Breakup Time
Description
This is a measure of tear stability with higher values being better (seconds).
Time Frame
Mean change at 6 months.
Title
Schirmer I Test
Description
This is a measure of tear volume with higher values being better (0 mm - 35 mm).
Time Frame
Mean change at 6 months.
Title
Corneal Staining
Description
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 15).
Time Frame
Mean change at 6 months.
Title
Conjunctival Staining
Description
This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).
Time Frame
Mean change at 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Provide informed consent and authorization to disclose protected health information
Willing to follow study protocol
Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye
Wear soft contact lenses as daily wear for at least 6 hours per day and at least 5 days per week for the past 30 days
Have at least a 2-hour difference between overall wear time and comfortable wear time of contact lenses
Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score ≥ 12)
Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report
Clinical assessment that contact lens material, fit, prescription, and care system are not reasons for contact lens discomfort
Demonstrate at least 80% compliance in completion of daily electronic diary (submitted through Qualtrics Research Suite) between V1 and V2
Willing to discontinue use of any current dry eye treatment (including use of commercial hygiene masks, and except for artificial tears) for 4 weeks before randomization and during the course of the 6-month study.
Exclusion Criteria:
Meibomian gland dropout ≥75% in either eyelid
Any changes to the contact lens material, fit, prescription, or care system in the 30 days preceding enrollment or anticipates needing to make changes during the course of the study
Any systemic disease known to be associated with dry eye
Any significant ocular surface abnormality that could be associated with ocular surface discomfort, such as ectropion, entropion, trichiasis, infection, severe allergic conjunctivitis, severe eyelid inflammation, etc.
Any overnight wear of contact lenses or use of daily disposable contact lenses
Any previous corneal surgery, including all types of corneorefractive surgery
Have temporary and/or permanent punctal plugs inserted
Use of supplemental fish oil, or seed oils from borage, evening primrose, sea buckthorn, flaxseed, or black currant within the last 60 days
Routine, usual dietary intake of more than 8 oz. of cold-water fatty fish (tuna, salmon, mackerel, sea bass, sardines or herring) per week).
Use of anticoagulant therapy or regular, daily use of aspirin, NSAIDs, or steroid medications within the past 30 days, or a history of easy bruising
Allergy or intolerance to fish or any ingredients contained in the active or placebo formulas [See appendix or ingredient list]
Participation in a clinical trial in the past 30 days
Current pregnancy or breast feeding as indicated by self-report
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly K Nichols, OD, PhD
Phone
(205) 975-9935
Email
nicholsk@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Candice D Turner, OD, PhD
Phone
(205) 934-0997
Email
citurner@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly K Nichols, OD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly K Nichols, OD, PhD
Phone
205-975-9975
Email
nicholsk@uab.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
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