Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
HydroEye®
Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
干预措施: HydroEye® (Drug)
Placebo
Subjects will take a total of four capsules daily, with meals (two capsules taken orally, twice a day).
干预措施: HydroEye® (Drug)
结局指标
主要结局
Average Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score
时间窗: 6 months
The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.
次要结局
- 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)
- Average Corneal Staining Score(6 months)
- Average Conjunctival Staining Score(6 months)
研究者
Kelly Nichols
Dean, Professor
University of Alabama at Birmingham