Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

Phase 4

Terminated

• Conditions: Dry Eye; Contact Lens Complication
• Interventions: Drug: HydroEye®

• Registration Number: NCT04163328
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-14
• Study Start: 2022-09-16
• Status Verified: 2024-08
• Primary Completion: 2024-08-21
• Study Completion: 2024-08-21
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HydroEye®	HydroEye®	Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
Placebo	HydroEye®	Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).

Primary Outcome Measures

Name	Time	Method
Contact Lens Dry Eye Questionnaire (CLDEQ-4)	Mean change at 6 months.	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

Name	Time	Method
Schirmer I Test	Mean change at 6 months.	This is a measure of tear volume with higher values being better (0 mm - 35 mm).
Conjunctival Staining	Mean change at 6 months.	This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 18).
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire	Mean change at 6 months.	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	Mean change at 6 months.	NPSI is a pain specific symptoms survey; range = 0-100 with 100 being most symptomatic.
Tear LTB4 Levels	Mean change at 6 months.	LTB4 values will be tested with a biochemical assay to estimate eye surface inflammation.
Tear Breakup Time	Mean change at 6 months.	This is a measure of tear stability with higher values being better (seconds).
Corneal Staining	Mean change at 6 months.	This is a measure of eye irritation with higher values being worse (NEI scale with range of 0 to 15).

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States