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

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

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

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: IC265 Ophthalmic Solution 1%; Drug: Placebo Ophthalmic Solution (Vehicle)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Iacta Pharma; Phone Number: 714-330-8532; Email: sj@iactapharma.com

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Recruiting
      • Iacta Selected Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IC265 Ophthalmic Solution 1%; 1 drop will be instilled in each eye twice daily.	Drug: IC265 Ophthalmic Solution 1%; 1 drop will be instilled in each eye twice a day
Placebo Comparator: Placebo Ophthalmic Solution (Vehicle); 1 drop will be instilled in each eye twice daily.	Drug: Placebo Ophthalmic Solution (Vehicle); 1 drop will be instilled in each eye twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescein staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score	The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).	Days 15, 43 and 85
Ocular discomfort and dry eye symptoms	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.	Days 15, 43 and 85
Lissamine green staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score	The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).	Days 15, 43 and 85
Tear film break-up time (TFBUT)	With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are > 2 seconds apart and are each < 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged.	Days 15, 43 and 85
Conjunctival Redness	Conjunctival Redness at Visits 3, 4 (pre-CAE, post-CAE, and pre- to post- CAE), and 5 (pre-CAE, post-CAE, and pre- to post-CAE), and mean change from baseline Visit 2 (Day 1) pre-CAE to Visit 5 (Day 85) pre-CAE	Days 15, 43 and 85 and mean change from Day 1 to Day 85
Ocular Surface Disease Index (OSDI)©	Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100.	Days 15, 43 and 85
Schirmer's test		Days 15, 43 and 85
Ocular discomfort during CAE		Days 43 and 85
Daily Diary Symptom Score		Daily Diary completed from Day 1 through Day 85

Collaborators and Investigators

• Sponsor: Iacta Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 23-110-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No