Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2023-03-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to compare the safety and efficacy of YP-P10 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05992922

Dry Eye Syndromes

TERMINATED PHASE2

A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

NCT07068958

Dry Eye Disease (DED)

NOT_YET_RECRUITING PHASE2

Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye

NCT04268069

Dry Eye Disease

COMPLETED PHASE2

Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye

NCT00799552

Dry Eye Syndrome

COMPLETED PHASE2

A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes

NCT03846453

Dry Eye

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The clinical hypotheses for this study is that 0.3% YP-P10 Ophthalmic Solution twice daily (BID) and 1.0% YP-P10 Ophthalmic Solution BID are superior to YP-P10 Placebo Ophthalmic Solution (vehicle) for the primary endpoints of signs and symptoms of dry eye, as follows:

* Sign: Total corneal fluorescein staining score of the study eye using the modified NEI grading scale, measured by mean change from baseline (Visit 2, Pre- Controlled Adverse Environment \[CAE®\]) to Visit 6
* Symptom: Ocular discomfort score of both eyes using the Visual Analog Scale (VAS) Ocular Discomfort Scale, measured by mean change from baseline (Visit 2, Pre-CAE®) to Visit 6

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicenter, randomized, double-masked, placebo-controlled clinical study. Subjects will be randomized to one of the following treatment arms at Visit 2 (Day 1):

* 0.3% YP-P10 Ophthalmic Solution: 1 drop BID in each eye (N = \~80)
* 1% YP-P10 Ophthalmic Solution: 1 drop BID in each eye (N = \~80)
* YP-P10 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = \~80)

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Before the initiation of study run-in at Visit 1, each subject who provides written informed consent will be assigned a screening number. All screening numbers will be assigned in strict numerical sequence at a site and no numbers will skipped or omitted. Each subject who meets all the inclusion and none of the exclusion criteria at Visit 1 and Visit 2 will be assigned a randomization number at the end of Visit 2. The Interactive Web Response System (IWRS) will be used to assign all randomization numbers.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.3% YP-P10 Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

0.3% YP-P10 Ophthalmic Solution

Intervention Type DRUG

Drug: YP-P10 Ophthalmic Solution

1% YP-P10 Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

1% YP-P10 Ophthalmic Solution

Intervention Type DRUG

Drug: YP-P10 Ophthalmic Solution

YP-P10 Placebo Ophthalmic Solution (vehicle)

Group Type PLACEBO_COMPARATOR

YP-P10 Placebo Ophthalmic Solution (vehicle)

Intervention Type DRUG

Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

0.3% YP-P10 Ophthalmic Solution

Drug: YP-P10 Ophthalmic Solution

Intervention Type DRUG

1% YP-P10 Ophthalmic Solution

Drug: YP-P10 Ophthalmic Solution

Intervention Type DRUG

YP-P10 Placebo Ophthalmic Solution (vehicle)

Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

• Individuals eligible to participate in this study must meet all of the following criteria: 0. Be at least 18 years of age;

1. Provide written informed consent;
2. Be willing and able to comply with all study procedures;
3. Have a patient-reported history of dry eye for at least 6 months prior to Visit 1;
4. Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
5. Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1;
6. Have a score of ≥ 2 for both eyes according to the Ora Calibra® Ocular Discomfort \& 4- Symptom Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2;
7. Have an unanesthetized Schirmer's Test score of ≤ 10 mm/5 minutes and ≥ 1 mm/5 minutes in at least one eye at Visits 1 and 2;
8. Have a corneal fluorescein staining score of ≥ 2 according to the Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in at least one region in one eye at Visits 1 and 2 and a central score ≥ 1 in the same eye;
9. Have a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 pre-CAE®;
10. Demonstrate in the same eye(s) 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; a. 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);
11. Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10 and 11 above;
12. A negative urine pregnancy test if female of childbearing potential (those who are not surgically sterilized \[bilateral tubal ligation, hysterectomy or bilateral oophorectomy\] or post-menopausal \[12 months after last menses\]) and must use adequate birth control through the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.)

Exclusion Criteria

1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
2. Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
3. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
4. Have used Restasis®, Xiidra®, or Cequa®, Eysuvis™ and Tyrvaya™ within 60 days of Visit 1;
5. Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period;
6. Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
7. Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); the respective wash- out periods are required for the following medications:

* Antihistamines (including ocular): 72 hours prior to Visit 1

1. Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period
2. Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1
3. Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study
4. All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1
8. Have an uncontrolled systemic disease;
9. Be a woman who is pregnant, nursing, or planning a pregnancy;
10. Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 6 (or early termination visit) if of childbearing potential. Non- childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy or tubal ligation), or is post- menopausal (without menses for 12 consecutive months);
11. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study;
12. Have a known allergy and/or sensitivity to the test article or its components;
13. Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
14. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
15. Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

Eligible Sex

ALL

Accepts Healthy Volunteers

No