Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal Pain (AURORA)
This study is designed to provide clinical data on how acoltremon ophthalmic solution 0.003% affects tear production and ocular symptoms in participants with tear deficiency and concurrent neuropathic corneal pain. Acoltremon is formulated to help increase natural tear production by activating TRPM8 (Transient Receptor Potential Melastatin 8) receptors on cold-sensitive corneal nerves. It is thought that this study treatment may help participants by increasing tear production while potentially reducing neuropathic ocular symptoms, including pain and discomfort.
Participants will be followed for 8 weeks, evaluating the mean change in unanesthetized Schirmer test score between 3 minutes post-drop at Week 8 compared to pre-drop at baseline (Day 1), change in neuropathic symptom intensity as measured by a 0-10 VAS (Visual Analog Scale) from baseline to Week 8, and change in quality of life as assessed by the Ocular Pain Assessment Survey (OPAS) from baseline to Week 8. The study will also evaluate changes in corneal nerve structure, nerve function, corneal sensitivity, ocular surface symptoms, and treatment satisfaction.
調査の概要
詳細な説明
AURORA is a prospective, open-label, single-center, single-arm investigator-initiated study evaluating TRYPTYR (acoltremon ophthalmic solution 0.003%) in 28 adults with neuropathic corneal pain and concurrent tear deficiency. Eligible participants must have neuropathic ocular symptoms for at least 3 months, a driving symptom score of at least 4 on a 0-10 VAS (Visual Analog Scale), reduced corneal nerve density and microneuromas on IVCM (In Vivo Confocal Microscopy), at least 50% symptom improvement following topical proparacaine, and an unanesthetized Schirmer score of at least 2 mm but less than 10 mm.
Participants will administer acoltremon 0.003% in both eyes twice daily for 8 weeks. One qualifying eye per participant will be designated as the study eye for analysis. There is no placebo or comparator group.
The primary endpoint is the mean change in unanesthetized Schirmer score from pre-drop baseline to 3 minutes post-drop at Week 8. Secondary endpoints include acute change in Schirmer score on Day 1, change in neuropathic ocular symptom intensity on the VAS (Visual Analog Scale), and change in quality of life measured by OPAS (Ocular Pain Assessment Survey). Exploratory outcomes include changes in corneal nerve structure and function, corneal sensitivity, OSDI (Ocular Surface Disease Index) scores, drop comfort, and treatment satisfaction.
Safety monitoring will focus on corneal staining, visual acuity, discomfort following drop administration, and adverse events, with a safety assessment conducted after the first five participants.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Mya L. Reese
- 電話番号：18139742020
- メール：MCOM-Eyeresearch@usf.edu
研究連絡先のバックアップ
- 名前：Susan Sherouse
- 電話番号：8139742020
- メール：MCOM-Eyeresearch@usf.edu
研究場所
-
-
Florida
-
Tampa、Florida、アメリカ、33612
- The University of South Florida
-
主任研究者：
- Pedram Hamrah, MD
-
コンタクト：
- Mya Reese
- 電話番号：8139742020
- メール：mreese179@usf.edu
-
コンタクト：
- Susan Sherouse
- 電話番号：8139742020
- メール：ssherous@usf.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male or female aged ≥ 18 years
- Baseline unanesthetized Schirmer test ≥2 and < 10 mm
- Symptoms of neuropathic corneal pain (such as burning, stinging, light sensitivity, discomfort, or pain) for at least 3 months with driving symptom rated at level 4 or higher on VAS.
- Positive IVCM findings evaluated by an experienced ophthalmologist (Pedram Hamrah, MD): for decreased nerve density AND evidence of microneuromas.
- Females of childbearing potential must have a negative pregnancy test.
- Change of 50% or more improvement in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX).
Exclusion Criteria:
- Evidence of any active ocular infection or any intraocular inflammation.
- Evidence of any persistent epithelial defect/ulcer or any corneal scar/corneal edema.
- Presence of any other ocular conditions that require topical medications during the treatment phase.
- History of severe systemic allergies or severe ocular allergies.
- Inability to suspend topical medications and varenicline 8 days prior to the starting date, except for artificial and serum tears for which subjects must be stable on current regimen for ≥3 months with no changes during the trial.
- History of any ocular surgery within three months before study Visit 1.
- Ocular surgery expected during the duration of the study.
- Use of refractive/therapeutic contact lenses during the study period.
- Female subjects who are pregnant/have a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.
- Drug addiction/alcohol abuse within the last year.
- Participation in another clinical trial concurrently.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Acoltremon Group
Patients will administer one drop of Acoltremon Ophthalmic Solution 0.003% twice a day for 8 weeks. |
acoltremon ophthalmic solution 0.003%, one drop, twice a day, into the study eye, for 8 weeks. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Unanesthetized Schirmer Test Score at Week 8
時間枠：Time frame: Baseline to Week 8
|
Mean change from the pre-dose measurement at baseline (Day 1) to the measurement taken 3 minutes after dosing at Week 8. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome. |
Time frame: Baseline to Week 8
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute Change in Unanesthetized Schirmer Test Score on Day 1
時間枠：Pre-dose to 3 minutes post-dose on Day 1
|
Mean change from the pre-dose measurement to the measurement taken 3 minutes after the first dose. Range: 0-35 mm Interpretation: Higher scores indicate greater tear production and a better outcome. |
Pre-dose to 3 minutes post-dose on Day 1
|
|
Change in Neuropathic Ocular Symptom Intensity
時間枠：Baseline to Week 8
|
Change in pain, discomfort, or another identified neuropathic symptom measured using a 0-10 visual analog scale (VAS). Range: 0-10 Interpretation: Higher scores indicate greater pain or symptom severity and a worse outcome. |
Baseline to Week 8
|
|
Change in Ocular Pain-Related Quality of Life
時間枠：Baseline to Week 8
|
Change in quality of life measured using the Ocular Pain Assessment Survey (OPAS). Range: 0-10 Interpretation: Higher scores indicate greater ocular pain and symptom severity and a worse outcome. |
Baseline to Week 8
|
協力者と研究者
協力者
捜査官
- 主任研究者：Pedram Hamrah, MD、University of South Florida/Ophthalmology
出版物と役立つリンク
一般刊行物
- Cruzat A, Qazi Y, Hamrah P. In Vivo Confocal Microscopy of Corneal Nerves in Health and Disease. Ocul Surf. 2017 Jan;15(1):15-47. doi: 10.1016/j.jtos.2016.09.004. Epub 2016 Oct 19.
- Qazi Y, Hurwitz S, Khan S, Jurkunas UV, Dana R, Hamrah P. Validity and Reliability of a Novel Ocular Pain Assessment Survey (OPAS) in Quantifying and Monitoring Corneal and Ocular Surface Pain. Ophthalmology. 2016 Jul;123(7):1458-68. doi: 10.1016/j.ophtha.2016.03.006. Epub 2016 Apr 16.
- Belmonte C, Nichols JJ, Cox SM, Brock JA, Begley CG, Bereiter DA, Dartt DA, Galor A, Hamrah P, Ivanusic JJ, Jacobs DS, McNamara NA, Rosenblatt MI, Stapleton F, Wolffsohn JS. TFOS DEWS II pain and sensation report. Ocul Surf. 2017 Jul;15(3):404-437. doi: 10.1016/j.jtos.2017.05.002. Epub 2017 Jul 20.
- Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
- Dieckmann G, Goyal S, Hamrah P. Neuropathic Corneal Pain: Approaches for Management. Ophthalmology. 2017 Nov;124(11S):S34-S47. doi: 10.1016/j.ophtha.2017.08.004.
- Villani E, Baudouin C, Efron N, Hamrah P, Kojima T, Patel SV, Pflugfelder SC, Zhivov A, Dogru M. In vivo confocal microscopy of the ocular surface: from bench to bedside. Curr Eye Res. 2014 Mar;39(3):213-31. doi: 10.3109/02713683.2013.842592. Epub 2013 Nov 11.
- Galor A, Levitt RC, Felix ER, Martin ER, Sarantopoulos CD. Neuropathic ocular pain: an important yet underevaluated feature of dry eye. Eye (Lond). 2015 Mar;29(3):301-12. doi: 10.1038/eye.2014.263. Epub 2014 Nov 7.
- Marfurt C, Anokwute MC, Fetcko K, Mahony-Perez E, Farooq H, Ross E, Baumanis MM, Weinberg RL, McCarron ME, Mankowski JL. Comparative Anatomy of the Mammalian Corneal Subbasal Nerve Plexus. Invest Ophthalmol Vis Sci. 2019 Dec 2;60(15):4972-4984. doi: 10.1167/iovs.19-28519.
- Marfurt CF, Cox J, Deek S, Dvorscak L. Anatomy of the human corneal innervation. Exp Eye Res. 2010 Apr;90(4):478-92. doi: 10.1016/j.exer.2009.12.010. Epub 2009 Dec 29.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- RTI #26-RCD0.16
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The University of South Florida Eye Institute is not a pharmacy distribution company, the information being collected is for medical science to improve patient care options.
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米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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