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

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

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • 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(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 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
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.	Change from Baseline Post-CAE® (controlled adverse environment) Day 15

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline Pre-CAE® (controlled adverse environment) in TFBUT in Study Eye Day 15
Ocular Surface Disease Index (OSDI)©	Change from baseline to Visit 3 (Day 15). Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. the OSDI© is a valid and reliable instrument for measure dry eye disease (normal, mild to moderate, and severe) and effects vision-related function.	Day 15
Schirmer's Test	Change from Baseline. Schirmer Tear Test will be performed according to the following procedure: Using a sterile Tear Flo Schirmer test strip, a bend in the strip will be made in line with the notch in the strip.; The subject will be instructed to gaze up and in.; The Schirmer test strip will be placed in the lower temporal lid margin of each eye such that the strip fits tightly. Subjects will be instructed to close their eyes.; After 5 minutes have elapsed, the Schirmer strip will be removed. The length of the moistened area will be recorded (mm) for each eye.	Day 15
Ocular Discomfort During CAE - Change From Baseline to Visit 3	Change from Baseline in Ora to Visit 3 Calibra® Ocular Discomfort Scale During the CAE® in the Study Eye. Ocular discomfort scores will be subjectively graded by the subjects according to the following scale: 0 - no discomfort, 1 - intermittent awareness, 2 - constant awareness, 3 - intermittent discomfort, 4 - constant discomfort.	Day 15
Daily Diary Symptom Score	Subject Daily Diary in the Evening - Day 8 to Day 14 average, 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.The average of the daily diary scores will be summarized using continuous descriptive statistics for the time period.	Daily Diary Evening - Day 8 to Day 14
Conjunctival Redness	Conjunctival Redness 5 point scale (0 - Normal, without vasodilation, 1 - Trace ciliary or conjunctival vasodilation, 2 - Broad ciliary vasodilation, 3 - Broad ciliary and slight, horizontal conjunctival vasodilation, 4 - Broad ciliary and prominent, horizontal conjunctival vasodilation)	Change from Baseline to Day 15
Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score	Change from Baseline Pre-CAE® in Corneal Lissamine Green Staining in Study Eye. 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).	Day 15
Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score	Change from Baseline Pre-CAE® to Post-CAE® in Corneal Fluorescein Staining in the Study Eye. 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).	Day 15

Collaborators and Investigators

• Sponsor: Iacta Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

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): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic 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