Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

NCT ID: NCT04163328

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-16
• Study Completion Date: 2024-08-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HydroEye®

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

Group Type: EXPERIMENTAL

HydroEye®

Intervention Type: DRUG

This is an omega-3 fatty acids supplement.

Placebo

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

Group Type: PLACEBO_COMPARATOR

HydroEye®

Intervention Type: DRUG

This is an omega-3 fatty acids supplement.

Interventions

HydroEye®

This is an omega-3 fatty acids supplement.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Kelly Nichols

Dean, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly K Nichols, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

000526521

Identifier Type: -

Identifier Source: org_study_id