Clinical trial NCT04163328: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Dry Eye
Contact Lens Complication
Keywords: HydroEye®
Contact Lens Discomfort
Dry Eye
Supplement
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: HydroEye® is a dietary omega 3 fatty acid 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Provide informed consent and authorization to disclose protected health information
3. Willing to follow study protocol
4. Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye
5. 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
6. Have at least a 2-hour difference between overall wear time and comfortable wear time of contact lenses
7. Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score ≥ 12)
8. Increased severity of dry eye symptoms with contact lens wear by at least 25% as determined by patient self-report
9. Clinical assessment that contact lens material, fit, prescription, and care system are not reasons for contact lens discomfort
10. Demonstrate at least 80% compliance in completion of daily electronic diary (submitted through Qualtrics Research Suite) between V1 and V2
11. 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:

1. Meibomian gland dropout ≥75% in either eyelid
2. 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
3. Any systemic disease known to be associated with dry eye
4. 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.
5. Any overnight wear of contact lenses or use of daily disposable contact lenses
6. Any previous corneal surgery, including all types of corneorefractive surgery
7. Have temporary and/or permanent punctal plugs inserted
8. Use of supplemental fish oil, or seed oils from borage, evening primrose, sea buckthorn, flaxseed, or black currant within the last 60 days
9. Routine, usual dietary intake of more than 8 oz. of cold-water fatty fish (tuna, salmon, mackerel, sea bass, sardines or herring) per week).
10. 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
11. Allergy or intolerance to fish or any ingredients contained in the active or placebo formulas \[See appendix or ingredient list\]
12. Participation in a clinical trial in the past 30 days
13. Current pregnancy or breast feeding as indicated by self-report

Primary outcomes:
measure: Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
timeFrame: 6 months
Secondary outcomes:
measure: Average of Tear LTB4 Levels in Picograms Per Milliliter
timeFrame: Baseline, 6 months
measure: Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score
timeFrame: 6 months
measure: Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score
timeFrame: 6 months
measure: Average Tear Breakup Time in Seconds
timeFrame: 6 months
measure: Average Schirmer I Test in mm
timeFrame: 6 months
measure: Average Corneal Staining Score
timeFrame: 6 months
measure: Average Conjunctival Staining Score
timeFrame: 6 months
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: Kelly K Nichols, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: