A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants

Last updated: April 8, 2025
Sponsor: Iacta Pharmaceuticals
Overall Status: Terminated

Phase

2

Condition

Dry Eyes

Sjogren's Syndrome

Eyelid Inflammation

Treatment

Placebo Ophthalmic Solution (Vehicle)

IC265 Ophthalmic Solution 1%

Clinical Study ID

NCT05992922
23-110-0002
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the safety, tolerability and efficacy of IC265 compared to vehicle in participants with signs and symptoms dry eye disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be at least 18 years of age;

  • Provide written informed consent

  • Have a reported or documented history of dry eye for at least 6 months prior toVisit 1

  • Have a history of use or desire to use eye drops for dry eye symptoms within 6months of Visit 1

  • Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at leastone symptom at Visits 1 and 2

  • Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2

  • Have a pre-CAE(controlled adverse environment) (conjunctival redness score ≥ 1according to the Conjunctival Redness for Dry Eye Scale in at least one eye atVisits 1 and 2

  • Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g.inferior, superior, or central) at Visits 1 and 2

  • Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of theinferior, superior, and central regions at Visits 1 and 2

  • Have a total lissamine green conjunctival score of ≥ 2, based on the sum of thetemporal and nasal regions at Visits 1 and 2

  • Demonstrate a response to the CAE at Visits 1 and 2 as defined by:

  1. Having at least a ≥1 point increase in fluorescein staining in the inferiorregion in at least one eye following CAE exposure

  2. Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points inat least one eye during CAE exposure (if a subject has an ocular discomfortrating of 3 at time = 0 for an eye, s/he must report an ocular discomfortrating of 4 for two consecutive measurements for that eye) Note: a subjectcannot have an ocular discomfort score of 4 at time = 0)

Exclusion

Exclusion Criteria:

  • Have any clinically significant slit lamp findings at Visit 1 that may includeactive blepharitis, meibomian gland dysfunction, ocular rosacea, lid margininflammation or active ocular allergies that require therapeutic treatment

  • Have any clinically significant (CS) posterior chamber findings, or a history ofsuch findings/disorders, that may include exudative (i.e., wet) age-related maculardegeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocularhypertension, or any other retinal or optic nerve disease/disorder that requiretherapeutic treatment and/or in the opinion of the Investigator may interfere withstudy parameters

  • Have worn contact lenses within 48 hours prior to Visit 1 or anticipate usingcontact lenses during the study

  • Have laser-assisted in situ keratomileusis (LASIK) or similar type of cornealrefractive surgery and/or any other ocular surgical procedure within 12 months priorto Visit 1; or have any ocular surgical procedure scheduled to be conducted duringthe study period

  • Have had any surgeries of the ocular surface or lid in the past 6 months

  • Have a history of lacrimal duct obstruction in either eye within 12 months prior toVisit 1

  • Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1or anticipate their use during the study period

  • Have permanent punctal plugs inserted or removed - including falling out - or havehad surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate anysuch event at any time during the study period

  • Use any of the following treatments in the period indicated before Visit 1 oranticipate their use at any time during the study

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo Ophthalmic Solution (Vehicle)
Phase: 2
Study Start date:
October 17, 2023
Estimated Completion Date:
December 19, 2023

Connect with a study center

  • Iacta Selected Site

    Andover, Massachusetts 01810
    United States

    Site Not Available

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