Clinical trial NCT05992922: A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants
Official title: A Phase 2, Single-Center, Randomized, Double- Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution 1% in Subjects Diagnosed With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: Iacta Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ocular Discomfort and Dry Eye Symptoms
timeFrame: Change from Baseline Post-CAE® (controlled adverse environment) Day 15
Secondary outcomes:
Other outcomes:
measure: Tear Film Break-up Time (TFBUT)
timeFrame: Change from Baseline Pre-CAE® (controlled adverse environment) in TFBUT in Study Eye Day 15
measure: Ocular Surface Disease Index (OSDI)©
timeFrame: Day 15
measure: Schirmer's Test
timeFrame: Day 15
measure: Ocular Discomfort During CAE - Change From Baseline to Visit 3
timeFrame: Day 15
measure: Daily Diary Symptom Score
timeFrame: Daily Diary Evening - Day 8 to Day 14
measure: Conjunctival Redness
timeFrame: Change from Baseline to Day 15
measure: Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
timeFrame: Day 15
measure: Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score
timeFrame: Day 15
Locations:
city: Andover
country: United States
facility: Iacta Selected Site
state: Massachusetts
Study officials:
References: