Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

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.

Study Overview

• Status: Terminated
• Conditions: Dry Eye; Contact Lens Complication
• Intervention / Treatment: Drug: HydroEye®

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HydroEye®; Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).	Drug: HydroEye®; This is an omega-3 fatty acids supplement.
Placebo Comparator: Placebo; Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).	Drug: HydroEye®; This is an omega-3 fatty acids supplement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average of Tear LTB4 Levels in Picograms Per Milliliter	If there is an adequate number of tear samples collected, LTB4 values will be tested with a biochemical assay to estimate eye surface inflammation. Pooled tears may be needed.	Baseline, 6 months
Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score	The SPEED is a dry eye specific symptoms survey, we are using the Rasch validated version; range = 0-28 with 28 being most symptomatic.	6 months
Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score	NPSI is a pain specific symptoms survey; range = 0-100 with 100 being most symptomatic. The survey is used to assess serious and chronic pain; therefore the number of subjects with non-zero NPSI values was expected to be minimal, and change to non-zero values was measured in treatment and placebo arms.	6 months
Average Tear Breakup Time in Seconds	This is a measure of tear stability with higher values being better (seconds).	6 months
Average Schirmer I Test in mm	This is a measure of tear volume with higher values being better (0 mm - 35 mm).	6 months
Average Corneal Staining Score	This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 15) with higher scores being worse.	6 months
Average Conjunctival Staining Score	This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).	6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Kelly K Nichols, OD, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Actual): August 21, 2024
• Study Completion (Actual): August 21, 2024

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dry Eye; Contact Lens Discomfort; Supplement; HydroEye®
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 000526521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No