Recruiting

Acoltremon

Sponsor:

University of South Florida

Code:

NCT07502378

Conditions

Ocular Surface Disease

Neurotrophic Keratopathy Stage 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.

Alternative would be patient exiting the trial and starting on tears or other standard of care.

Study Details

Brief summary:

STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.

Conditions

Ocular Surface Disease

Neurotrophic Keratopathy Stage 1

Study ID

NCT07502378

Start date

Apr 6, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Neurotrophic Keratopathy stage 1 diagnosis based on the following: Presence of 3+ fluorescein staining in central cornea and decreased corneal sensation (Cochet-Bonnet less than 4cm in the central cornea)
  • Baseline unanesthetized Schirmer's test ≤ 10 mm
  • Females of childbearing potential must have a negative pregnancy test.
  • Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200).

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 8 days prior to the starting date and artificial tears 2 hours prior to the first study visit and remain off for the duration of the study.
  • 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.
  • Participation in another clinical trial concurrently

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Acoltremon 0.003% Ophthalmic Solution

Open Label treatment of Acoltremon

Interventions

Patients will receive topical Acoltremon 0.003% ophthalmic solution BID in both eyes over an 8 week period.

This is an FDA approved drug. The participants will be educated on the potential instillation site sensation that may occur as reported from the Pivotal Trials and that the sensation may differ between eyes due to the Neurotrophic Keratopathy.

Qualified eyes must meet the inclusion and exclusion criteria. If both eyes qualify, then the one with the worst vision will be the study eye. If both eyes have equal visual acuity then the right eye will be the study eye.

Alternative would be patient exiting the trial and starting on tears or other standard of care.

This is an open label trial. If the patient does not do well on Acoltremon Ophthalmic Solution, then the participant will be removed from trial and put on standard of care treatment, other than Acoltremon.

Primary outcome measure

  • Unanesthetized Schirmer Test [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Pedram Hamrah, MD

813-974-0948phamrah@usf.edu

Susan Sherouse

813-974-0948ssherous@usf.edu

Locations

University of South Florida/Ophthalmology

Recruiting

Tampa, Florida, United States, 33612

Contacts

Angie Windham

813-974-1423angiewindham@usf.edu

Susan Sherouse

813-974-0948ssherous@usf.edu

Principal Investigator:

Pedram Hamrah, MD

More Information

Sponsor

University of South Florida

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Ocular Surface Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-08-12.