Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort

Phase 4

Terminated

• Conditions: Dry Eye; Contact Lens Complication

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-12
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age =18 years<br><br> 2. Provide informed consent and authorization to disclose protected health information<br><br> 3. Willing to follow study protocol<br><br> 4. Habitual, contact lens-corrected visual acuity of at least 20/30 in each eye<br><br> 5. Wear soft contact lenses as daily wear for at least 6 hours per day and at least 5<br> days per week for the past 30 days<br><br> 6. Have at least a 2-hour difference between overall wear time and comfortable wear<br> time of contact lenses<br><br> 7. Have symptoms consistent with Contact Lens Dry Eye based on CLDEQ-8 (score = 12)<br><br> 8. Increased severity of dry eye symptoms with contact lens wear by at least 25% as<br> determined by patient self-report<br><br> 9. Clinical assessment that contact lens material, fit, prescription, and care system<br> are not reasons for contact lens discomfort<br><br> 10. Demonstrate at least 80% compliance in completion of daily electronic diary<br> (submitted through Qualtrics Research Suite) between V1 and V2<br><br> 11. Willing to discontinue use of any current dry eye treatment (including use of<br> commercial hygiene masks, and except for artificial tears) for 4 weeks before<br> randomization and during the course of the 6-month study.<br><br>Exclusion Criteria:<br><br> 1. Meibomian gland dropout =75% in either eyelid<br><br> 2. Any changes to the contact lens material, fit, prescription, or care system in the<br> 30 days preceding enrollment or anticipates needing to make changes during the<br> course of the study<br><br> 3. Any systemic disease known to be associated with dry eye<br><br> 4. Any significant ocular surface abnormality that could be associated with ocular<br> surface discomfort, such as ectropion, entropion, trichiasis, infection, severe<br> allergic conjunctivitis, severe eyelid inflammation, etc.<br><br> 5. Any overnight wear of contact lenses or use of daily disposable contact lenses<br><br> 6. Any previous corneal surgery, including all types of corneorefractive surgery<br><br> 7. Have temporary and/or permanent punctal plugs inserted<br><br> 8. Use of supplemental fish oil, or seed oils from borage, evening primrose, sea<br> buckthorn, flaxseed, or black currant within the last 60 days<br><br> 9. Routine, usual dietary intake of more than 8 oz. of cold-water fatty fish (tuna,<br> salmon, mackerel, sea bass, sardines or herring) per week).<br><br> 10. Use of anticoagulant therapy or regular, daily use of aspirin, NSAIDs, or steroid<br> medications within the past 30 days, or a history of easy bruising<br><br> 11. Allergy or intolerance to fish or any ingredients contained in the active or placebo<br> formulas [See appendix or ingredient list]<br><br> 12. Participation in a clinical trial in the past 30 days<br><br> 13. Current pregnancy or breast feeding as indicated by self-report

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contact Lens Dry Eye Questionnaire (CLDEQ-4)

Secondary Outcome Measures

Name	Time	Method
Tear LTB4 Levels;Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire;Neuropathic Pain Symptom Inventory (NPSI) Questionnaire;Tear Breakup Time;Schirmer I Test;Corneal Staining;Conjunctival Staining