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

Iacta Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: IC265 Ophthalmic Solution 1%; Drug: Placebo Ophthalmic Solution (Vehicle)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05992922

23-110-0002

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 to Visit 1

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

• Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at least one 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 ≥ 1 according to the Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 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 the inferior, superior, and central regions at Visits 1 and 2

• Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal 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 inferior region in at least one eye following CAE exposure
  2. Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure (if a subject has an ocular discomfort rating of 3 at time = 0 for an eye, s/he must report an ocular discomfort rating of 4 for two consecutive measurements for that eye) Note: a subject cannot have an ocular discomfort score of 4 at time = 0)

Exclusion criteria

• Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation or active ocular allergies that require therapeutic treatment
• Have any clinically significant (CS) posterior chamber findings, or a history of such findings/disorders, that may include exudative (i.e., wet) age-related macular degeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocular hypertension, or any other retinal or optic nerve disease/disorder that require therapeutic treatment and/or in the opinion of the Investigator may interfere with study parameters
• Have worn contact lenses within 48 hours prior to Visit 1 or anticipate using contact lenses during the study
• Have laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery and/or any other ocular surgical procedure within 12 months prior to Visit 1; or have any ocular surgical procedure scheduled to be conducted during the 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 to Visit 1
• Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1 or anticipate their use during the study period
• Have permanent punctal plugs inserted or removed - including falling out - or have had surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate any such event at any time during the study period
• Use any of the following treatments in the period indicated before Visit 1 or anticipate their use at any time during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

IC265 Ophthalmic Solution 1%

Experimental group

Description:

1 drop will be instilled in each eye twice daily.

Treatment:

Drug: IC265 Ophthalmic Solution 1%

Placebo Ophthalmic Solution (Vehicle)

Placebo Comparator group

Description:

1 drop will be instilled in each eye twice daily.

Treatment:

Drug: Placebo Ophthalmic Solution (Vehicle)