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Dry Eye Disease (DED)ASTRANCT07268599

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

An observational study of Dry Eye Disease (DED), run by Colvard Kandavel Eye Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Dry Eye Disease (DED)
What is being tested?
Acoltremon
How many people
50 participants
Where
1 siteUnited States
Study dates
24 Nov 2025to Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Adult

Study population: Colvard-Kandavel Eye Center patients

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Colvard-Kandavel Eye Center

    Encino, California, 91316

Other trials in United States

About this study

Official title: Acoltremon Symptom Tracking and Relief Assessment in Moderate-to-Severe Dry Eye Disease

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.

Being tested
Acoltremon
Keywords
Dry Eye, Dry Eye Disease, Acoltremon
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcoltremonDrug

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start24 Nov 2025
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07268599
Sponsor's protocol ID
ASTRA-25859
Acronym
ASTRA
Status last verified
Dec 2025
First submitted
21 Nov 2025
Last updated
8 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 26905373

  • 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.

    PubMed 28079022

  • 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.

    PubMed 39985746

  • 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.

    PubMed 38771801

  • 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.

    PubMed 28736342

  • 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.

    PubMed 20065224

  • 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.

    PubMed 10815152

  • 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.

    PubMed 27257373

  • 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.

    PubMed 23710423

  • 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.

    PubMed 20467319

  • 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.

    PubMed 28797892

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye Disease (DED), run by Colvard Kandavel Eye Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Ocular Surface Disease Index at 28 days (time frame: Baseline and 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07268599, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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