Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon
NCT ID: NCT07268599
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
50 participants
OBSERVATIONAL
2025-11-24
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Acoltremon
Patients will administer Acoltremon 0.003% as per labeled directions. Assessments with the Ocular Surface Disease Index (OSDI) will occur at Baseline, treatment at 14 days, and treatment at 28 days. Secondary endpoints include change from baseline rating scale 1-5 in severity of various symptoms of dry eye: Blurriness, eye irritation/Discomfort, Burning/Stinging, Photophobia/Pain, Sandy/gritty/Foreign Body Sensation, Fatigue/Tired Eyes).
Eligibility Criteria
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Inclusion Criteria
* Use or desire for artificial tears for DED symptoms within past 2 months
* OSDI score \>25 and \<50 at Screening
* TBUT \<10 seconds
* Baseline tCFS score ≥2 and ≤15 (modified NEI)
Exclusion Criteria
* History of herpes zoster ophthalmicus, herpes simplex virus keratitis, or other viral corneal infection
* History of neurotrophic keratitis
* Prior significant facial trauma or sinus surgery
* Mental or physical condition impairing ability to complete questionnaires
* Use of Restasis®, Xiidra®, or Miebo within 30 days
* Use of other topical anti-inflammatory medications within 30 days
* Use of varenicline nasal spray within 30 days
* Use of artificial tears within 2 hours prior to screening or during study period
* Glaucoma requiring topical therapy
* Contact lens or eyelid scrub use within 7 days
* Punctal plugs within 14 days
* Oxervate historical use
* Amniotic membrane or Serum Tears historical use
* History of Sjögren's disease
* History of LASIK within 1 year
18 Years
60 Years
ALL
No
Sponsors
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Colvard Kandavel Eye Center
OTHER
Responsible Party
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Ganesha Kandavel
Principal Investigator
Principal Investigators
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Ganesha R Kandavel, MD
Role: PRINCIPAL_INVESTIGATOR
Colvard Kandavel Eye Center
Locations
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Colvard-Kandavel Eye Center
Encino, California, United States
Countries
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References
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Pucker AD, Ng SM, Nichols JJ. Over the counter (OTC) artificial tear drops for dry eye syndrome. Cochrane Database Syst Rev. 2016 Feb 23;2(2):CD009729. doi: 10.1002/14651858.CD009729.pub2.
Dry eye redefined: TFOS DEWS II report; 2017; 1-6. https://www.tfosdewsreport.org. Accessed 18 Feb 2022.
Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.
Bacharach J, Kannarr SR, Verachtert A, Gupta PK, Razeen M, Cavet ME, Vittitow JL, Lang J, Chester TM, Ziemanski JF, White DE. Early Effects of Perfluorohexyloctane Ophthalmic Solution on Patient-Reported Outcomes in Dry Eye Disease: A Prospective, Open-Label, Multicenter Study. Ophthalmol Ther. 2025 Apr;14(4):693-704. doi: 10.1007/s40123-025-01097-z. Epub 2025 Feb 22.
Wirta DL, Galor A, Aune CA, Vollmer PM, Liang E, Meides AS, Krosser S. Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE. Cornea. 2024 May 21;44(6):692-700. doi: 10.1097/ICO.0000000000003567.
Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
Miller KL, Walt JG, Mink DR, Satram-Hoang S, Wilson SE, Perry HD, Asbell PA, Pflugfelder SC. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol. 2010 Jan;128(1):94-101. doi: 10.1001/archophthalmol.2009.356.
Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
Stonecipher KG, Torkildsen GL, Ousler GW 3rd, Morris S, Villanueva L, Hollander DA. The IMPACT study: a prospective evaluation of the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye. Clin Ophthalmol. 2016 May 13;10:887-95. doi: 10.2147/OPTH.S101627. eCollection 2016.
Uchino M, Schaumberg DA. Dry Eye Disease: Impact on Quality of Life and Vision. Curr Ophthalmol Rep. 2013 Jun;1(2):51-57. doi: 10.1007/s40135-013-0009-1.
Friedman NJ. Impact of dry eye disease and treatment on quality of life. Curr Opin Ophthalmol. 2010 Jul;21(4):310-6. doi: 10.1097/ICU.0b013e32833a8c15.
Craig JP, Nelson JD, Azar DT, Belmonte C, Bron AJ, Chauhan SK, de Paiva CS, Gomes JAP, Hammitt KM, Jones L, Nichols JJ, Nichols KK, Novack GD, Stapleton FJ, Willcox MDP, Wolffsohn JS, Sullivan DA. TFOS DEWS II Report Executive Summary. Ocul Surf. 2017 Oct;15(4):802-812. doi: 10.1016/j.jtos.2017.08.003. Epub 2017 Aug 8.
Other Identifiers
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ASTRA-25859
Identifier Type: -
Identifier Source: org_study_id
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