Efficacy of Switching Participants Treated With Restasis to TRYPTYR
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1
研究概览
简要总结
Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. 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). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.
详细描述
Acoltremon 0.003% 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.9, 10 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.9 This drugs subsequently modulates cold thermoreceptor to increase tear production and promote a cooling sensation, which promotes symptomatic relief. While acoltremon 0.003% has been significantly shown to improve the signs and symptoms of DED patient, the community currently lacks data describing how patients who are being treated with Restasis (cyclosporine ophthalmic emulsion), yet are not having their expectations met with the drug, respond to being switched to acoltremon 0.003%. These data are important because they could demonstrate that a DED drug with a different mechanism of action can still be effective when another treatment does not meet the patient's expectations. Thus, the purpose of this study is to determine if acoltremon 0.003% can significantly improve the signs and symptoms of DED suffers who are not currently being successfully treated with Restasis.
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 100 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
acoltremon 0.003%.
Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline.
干预措施: acoltremon 0.003% (Drug)
结局指标
主要结局
Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1
时间窗: 1 day
schirmers strip wetting/time will be measured between pre and post drop. With quicker wetting with greater voulme being considered better.
次要结局
- Change in SPEED scores(14 days)