Evaluating the Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Mean change from baseline in IDEEL-QoL Work scores at 28 days.
研究概览
简要总结
This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults ≥18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score ≥40) will be recruited. Subjects will have an abnormal Schirmer test of <10 mm/5 min. Subjects will also be required to score ≤70 on the IDEEL Quality of Life (QoL) Work domain to ensure that their DED symptoms are significantly impacting their ability to do work.9 Subjects will be required to have corrected distance visual acuity of 20/32 (0.2 logMAR) or better.
详细描述
Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly.1-3 DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED).4 Unfortunately, there is not a perfect correlation between DED signs and symptoms,5 which makes diagnosis and timely treatment challenging. With DED symptoms often being bothersome and there being a lack of universally effective treatment options,6 DED patients are significantly more likely to suffer from a decreased quality of life and a psychological condition such depression.7 Thus, the DED patient population would strongly benefit from new, innovative treatments that are based upon a novel mechanism.
Acoltremon 0.003% (TRYPTYR; Alcon Laboratories; Fort Worth, TX, USA) was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor potential melastatin 8 (TRPM8) agonist for the treatment of DED.8 Acoltremon acts by activating TRPM8 receptors expressed on the neurons of the ophthalmic division of the trigeminal nerve, which is the nerve that innervates the cornea and eyelid.8 This drugs subsequently stimulates cold thermoreceptor to increase tear production. While acoltremon 0.003% has been significantly shown to improve tear production and symptoms as measured by the Symptom Assessment in Dry Eye (SANDE) at 14- and 28-days post-treatment, the community currently lacks data related to key measures of quality of life such as one's ability to work and perform daily tasks. Thus, the purpose of this study is to determine if acoltremon 0.003% can significantly improve the quality of life of DED suffers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age.
- •Have a history of DED for at least the past 6 months.
- •Are currently using Restasis as directed by their eye care provider for ≥1 month.
- •Participant intends to stop Restasis in the near future because and expressed dissatisfaction with effectiveness of Restasis in reducing dry eye symptoms..
- •Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score [≥2 to <10 mm/5 min]) at Screening/Baseline.
- •Have corrected distance visual acuity of 20/100 or better.
- •Willing to discontinue contact lens wear throughout the study.
排除标准
- •Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- •Have a history of ocular surgery within the past 12 months.
- •Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- •Punctal plugs in place for < 3 months and/or Lacrifill in place for > 5 months.
- •Have ever used Accutane or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry, except for Restasis).
- •Use of artificial tears within 2 hours prior to the baseline visit or during the study.
- •Are pregnant or breast feeding.
- •Have had a physical meibomian gland treatment withing 1 month of enrollment.
- •Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.
研究组 & 干预措施
TRYPTYR
Participants who qualify for the study will be given TRYPTYR to determine if it is able to help alleviate symptoms associated with dry eye disease;
干预措施: Acoltremon (Drug)
结局指标
主要结局
Mean change from baseline in IDEEL-QoL Work scores at 28 days.
时间窗: 1 month
the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr
次要结局
- Mean change from baseline in IDEEL-QoL Work scores at 14 days.(14 days)