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

NCT05992922 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 23-110-0002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Tear Film Break-up Time (TFBUT)

  Change from Baseline Pre-CAE® (controlled adverse environment) in TFBUT in Study Eye Day 15

• Ocular Surface Disease Index (OSDI)©

  Day 15

• Schirmer's Test

  Day 15

Study Arms (2)

IC265 Ophthalmic Solution 1%

EXPERIMENTAL

1 drop will be instilled in each eye twice daily.

Drug: IC265 Ophthalmic Solution 1%

Placebo Ophthalmic Solution (Vehicle)

PLACEBO COMPARATOR

1 drop will be instilled in each eye twice daily.

Drug: Placebo Ophthalmic Solution (Vehicle)

Interventions

IC265 Ophthalmic Solution 1% DRUG

1 drop will be instilled in each eye twice a day

IC265 Ophthalmic Solution 1%

Placebo Ophthalmic Solution (Vehicle) DRUG

1 drop will be instilled in each eye twice a day

Placebo Ophthalmic Solution (Vehicle)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE exposure
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Iacta Pharmaceuticals: lead

Study Sites (1)

Iacta Selected Site

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

The study was terminated early, Visit 3 Day 15, due to the unexpected epithelial haze findings in several subjects on IC265. All but one AEs of epithelial haze observed in several of subjects in IC265 OS 1% were mild and resolved without intervention in all cases. The study was discontinued in the abundance of caution.

Results Point of Contact

• Title: Chief Operating Officer
• Organization: Iacta Pharmaceuticals

sj@iactapharma.com

714-330-8532

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: October 17, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: April 25, 2025
• Results First Posted: April 25, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)