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

NCT ID: NCT05992922

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2023-12-19

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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IC265 Ophthalmic Solution 1%

1 drop will be instilled in each eye twice daily.

Group Type: EXPERIMENTAL

IC265 Ophthalmic Solution 1%

Intervention Type: DRUG

1 drop will be instilled in each eye twice a day

Placebo Ophthalmic Solution (Vehicle)

1 drop will be instilled in each eye twice daily.

Group Type: PLACEBO_COMPARATOR

Placebo Ophthalmic Solution (Vehicle)

Intervention Type: DRUG

1 drop will be instilled in each eye twice a day

Interventions

IC265 Ophthalmic Solution 1%

1 drop will be instilled in each eye twice a day

Intervention Type: DRUG

Placebo Ophthalmic Solution (Vehicle)

1 drop will be instilled in each eye twice a day

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iacta Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Iacta Selected Site

Andover, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

23-110-0002

Identifier Type: -

Identifier Source: org_study_id