Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

NCT04163328 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 000526521
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Contact Lens Complication

Keywords

HydroEye®; Contact Lens Discomfort; Dry Eye; Supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Average of Tear LTB4 Levels in Picograms Per Milliliter

  Baseline, 6 months

• Average Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score

  6 months

• Number of Participants With a Non-zero Neuropathic Pain Symptom Inventory (NPSI) Questionnaire Score

  6 months

• Average Tear Breakup Time in Seconds

  6 months

• Average Schirmer I Test in mm

  6 months

Study Arms (2)

HydroEye®

EXPERIMENTAL

Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).

Drug: HydroEye®

Placebo

PLACEBO COMPARATOR

Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).

Drug: HydroEye®

Interventions

HydroEye® DRUG

This is an omega-3 fatty acids supplement.

HydroEye®; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

The study was terminated by the sponsor. Covid impacted recruitment and the active and placebo self-life was exceeded.

Results Point of Contact

• Title: Dr. Kelly K. Nichols
• Organization: UAB

nicholsk@uab.edu

205-975-9935

Study Officials

• Kelly K Nichols, OD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Professor

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 14, 2019
• Study Start: September 16, 2022
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)