Switching From Xiidra to TRYPTYR

Официальное название

Efficacy of Switching Participants Treated With Xiidra to TRYPTYR

Обзор

To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%. Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

Подробное описание

This prospective, single-masked (participant), single-armed, study will determine how participants who are being treated with Xiidra respond to acoltremon 0.003%. Pre- to post-drop Schirmer's test scores at Day 1 will be the primary outcome. Some studies found the Day 1 mean differences for pre- to post-drop Schirmer's test score was 8.9, and the 28 Day mean differences for pre- to post-drop Schirmer's test score was 10.6 0.58 mm. If one assumes a clinically meaningful difference of 3 units (SD = 0.58; α of 0.05 and power of 80%), a total of 3 subjects will be needed to determine if there is a significant change in pre- to post-drop Schirmer's test scores. SPEED questionnaire at Days 14 and 28 will be the secondary outcomes. SPEED questionnaire scores of 2.2, 5.0, 6.6, and 9.9 corresponded to having asymptomatic, mild, moderate, and severe dry eye symptoms, and as such a 3 unit change will be considered to be a clinically meaningful difference.11 Asiedu et al. found that the typical subject with moderate dry eye has a mean SD SPEED score of 6.6 , which is the target symptoms severity level of this study.11 If one assumes a clinically meaningful difference of 3 units (SD = 4.1; α of 0.05 and power of 80%), a total of 17 subjects will be needed to determine if there is a significant change in SPEED scores at day 14 or 28. Exploratory outcomes include Likert survey questions; thus, the overall sample size will be inflated to 100 participants to help ensure that representative survey responses are obtained from the participants included in this study.

Вмешательства

• Препарат acoltremon 0.003%
  Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

Первичные конечные точки

• Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1 [Срок оценки: 1 day]

Вторичные конечные точки (2)

• Change in standardized speed scores [Срок оценки: 28 days]
• 2 week change in standardized speed scores [Срок оценки: 14 days]

Критерии участия

Критерии включения

• Adults ≥18 years of age.
• Have a history of DED for at least the past 6 months.
• Are currently using Xiidra as directed by their eye care provider for ≥1 month.
• Are symptomatic as determined with SPEED (≥7) and have an abnormal Schirmer test score \[≥2 to <10 mm/5 min\]) at Screening/Baseline. If Shirmer only qualifies for one eye, that will be the study eye. If Shirmer qualifies for both eyes, the right eye will be the study eye.
• Have corrected distance visual acuity of 20/40 or better.
• Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.

Критерии исключения

• 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
• Currently using ocular medications, including topical anti-inflammatory drops, (other than Xiidra) 1 month prior to enrollment
• Any artificial tear use at enrollment must remain consistent throughout the study.
• Are pregnant or breast feeding.
• Have had a physical meibomian gland treatment withing 1 month of enrollment.
• Initiated, discontinued or changed dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) within 14 days of the screening visit.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07267481 · IRB00006763-Xiidra

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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