Dry Eye SyndromesPhase 2NCT05992922

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

A Phase 2 study testing IC265 Ophthalmic Solution 1% in people with Dry Eye Syndromes, run by Iacta Pharmaceuticals at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: IC265 Ophthalmic Solution 1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 17 Oct 2023to 19 Dec 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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)

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Iacta Selected Site
Andover, Massachusetts, 01810

Other trials in United States

About this study

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

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
Being tested: IC265 Ophthalmic Solution 1%, Placebo Ophthalmic Solution (Vehicle)
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IC265 Ophthalmic Solution 1%Drug
1 drop will be instilled in each eye twice a day
Placebo Ophthalmic Solution (Vehicle)Drug
1 drop will be instilled in each eye twice a day

Study groups in NCT05992922
Study group	Role	What they receive
IC265 Ophthalmic Solution 1%	Experimental	1 drop will be instilled in each eye twice daily. Receives: Drug: IC265 Ophthalmic Solution 1%
Placebo Ophthalmic Solution (Vehicle)	Placebo comparator	1 drop will be instilled in each eye twice daily. Receives: Drug: Placebo Ophthalmic Solution (Vehicle)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from Baseline Post-CAE® (controlled adverse environment) Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 202319 Dec 2023

First posted15 Aug 2023
Study start17 Oct 2023
Primary completion19 Dec 2023
Study completion19 Dec 2023

Why it stopped: Unexpected adverse events were observed in a subset of patients on drug. In an over abundance of caution the study was terminated. All adverse events resolved with no sequelae.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05992922
Sponsor's protocol ID: 23-110-0002
Status last verified: Sep 2024
First submitted: 8 Aug 2023
Last updated: 25 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)

All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05992922
Acronym / sponsor ID: 23-110-0002
Conditions: Dry Eye Syndromes
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unexpected adverse events were observed in a subset of patients on drug. In an over abundance of caution the study was terminated. All adverse events resolved with no sequelae.
Enrolment: 40 participants (actual)
Lead sponsor: Iacta PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 17 Oct 2023 (actual)
Primary completion: 19 Dec 2023 (actual)
Study completion: 19 Dec 2023 (actual)
First posted: 15 Aug 2023 (actual)
Results: Posted 25 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IC265 Ophthalmic Solution 1%	Experimental	Drug: IC265 Ophthalmic Solution 1%1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle)	Placebo comparator	Drug: Placebo Ophthalmic Solution (Vehicle)1 drop will be instilled in each eye twice daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IC265 Ophthalmic Solution 1%1 drop will be instilled in each eye twice a day	Drug	IC265 Ophthalmic Solution 1%
Placebo Ophthalmic Solution (Vehicle)1 drop will be instilled in each eye twice a day	Drug	Placebo Ophthalmic Solution (Vehicle)

Primary outcome

Ocular Discomfort and Dry Eye Symptoms
Time frame: Change from Baseline Post-CAE® (controlled adverse environment) Day 15
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.

Results and safety

Results posted to the registry on 25 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IC265 Ophthalmic Solution 1%	20	0
Placebo Ophthalmic Solution (Vehicle)	20	0

Primary outcome: Ocular Discomfort and Dry Eye Symptoms

Time frame: Change from Baseline Post-CAE® (controlled adverse environment) Day 15. Mean (Standard Deviation). Unit: score on a scale

Measure	IC265 Ophthalmic Solution 1% n = 14	Placebo Ophthalmic Solution (Vehicle) n = 19
Overall Ocular Discomfort	-0.6 (1.09)	0.3 (0.82)
Burning	-0.5 (1.34)	-0.7 (1.38)
Dryness	-0.7 (1.27)	0.3 (0.56)
Grittiness	-0.4 (1.22)	0.2 (1.38)
Stinging	-0.8 (1.63)	-0.1 (1.15)

Population analysed: Intent to Treat - only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.

Adverse events

Time frame: The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IC265 Ophthalmic Solution 1%	1 of 20 (5%)	20 of 20 (100%)	0 of 20
Placebo Ophthalmic Solution (Vehicle)	0 of 20 (0%)	5 of 20 (25%)	0 of 20

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dry Eye Syndromes

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IC265 Ophthalmic Solution 1% in people with Dry Eye Syndromes, run by Iacta Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Discomfort and Dry Eye Symptoms (time frame: Change from Baseline Post-CAE® (controlled adverse environment) Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05992922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.