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

Phase 2

Terminated

Conditions: Dry Eye Syndromes

Interventions: Drug: Placebo Ophthalmic Solution (Vehicle)
Drug: IC265 Ophthalmic Solution 1%

Registration Number: NCT05992922

Lead Sponsor: Iacta Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Ophthalmic Solution (Vehicle)	Placebo Ophthalmic Solution (Vehicle)	1 drop will be instilled in each eye twice daily.
IC265 Ophthalmic Solution 1%	IC265 Ophthalmic Solution 1%	1 drop will be instilled in each eye twice daily.

Primary Outcome Measures

Name	Time	Method
Ocular Discomfort and Dry Eye Symptoms	Change from Baseline Post-CAE® (controlled adverse environment) Day 15	Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.

Secondary Outcome Measures