Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

NCT07268599 | Enrolling By Invitation FDA Drug

• 1 other identifier: ASTRA-25859
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the impact of Acoltremon 0.003% on subjective dry eye symptoms using validated patient-reported outcome measures: Eye Dryness Score Visual Analog Scale (EDS-VAS). The primary aim is to characterize the rapidity of symptomatic relief in moderate to severe dry eye disease (DED), with attention to short-term therapy.

Conditions

Dry Eye Disease (DED)

Keywords

Dry Eye; Dry Eye Disease; Acoltremon

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Ocular Surface Disease Index at 28 days

  Change from baseline in specific 1-5 categorical rating scale scoring at 28 days of dry eye symptoms: Blurriness, burning/stinging, eye irritation/discomfort, photophobia/pain, tired eyes/eye fatigue, sandy/gritty/foreign body sensation

  Baseline and 28 days

Interventions

Acoltremon DRUG

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

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Colvard-Kandavel Eye Center patients

You may qualify if:

• Adults aged 18 years or older with clinical diagnosis of DED within past 6 months
• 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)

You may not qualify if:

• History of corneal or conjunctival surgery
• 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

Sponsors & Collaborators

• Colvard Kandavel Eye Center: lead

Study Sites (1)

Colvard-Kandavel Eye Center

Encino, California, 91316, United States

Location

Related Publications (12)

• 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.

  PMID: 26905373 BACKGROUND

• Dry eye redefined: TFOS DEWS II report; 2017; 1-6. https://www.tfosdewsreport.org. Accessed 18 Feb 2022.

  BACKGROUND

• 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.

  PMID: 28079022 BACKGROUND

• 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.

  PMID: 39985746 BACKGROUND

• 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.

  PMID: 38771801 BACKGROUND

• 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.

  PMID: 28736342 BACKGROUND

• 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.

  PMID: 20065224 BACKGROUND

• 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.

  PMID: 10815152 BACKGROUND

• 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.

  PMID: 27257373 BACKGROUND

• 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.

  PMID: 23710423 BACKGROUND

• 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.

  PMID: 20467319 BACKGROUND

• 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.

  PMID: 28797892 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Ganesha R Kandavel, MD

  Colvard Kandavel Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 8, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)