Phase 2
Completed N=257
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)
Source: ClinicalTrials.gov NCT05467293 ↗Enrolled (actual)
257
Serious AEs
0.8%
Results posted
Jul 2024
Primary outcomePrimary: Total Corneal Fluorescein Staining — 7.35; 7.25; 7.12 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Corneal Fluorescein Staining |
7.35; 7.25; 7.12 | — |
| PRIMARY Ocular Discomfort Score |
52.8; 54.2; 53.6 | — |
| SECONDARY Fluorescein Staining: Inferior |
1.71; 1.71; 1.73 | — |
| SECONDARY Fluorescein Staining: Superior |
1.34; 1.36; 1.26 | — |
| SECONDARY Fluorescein Staining: Central |
1.33; 1.28; 1.29 | — |
| SECONDARY Fluorescein Staining: Temporal |
1.36; 1.33; 1.29 | — |
| SECONDARY Fluorescein Staining: Nasal |
1.60; 1.57; 1.55 | — |
| SECONDARY Lissamine Green Staining: Conjunctival Sum |
5.36; 4.96; 5.62 | — |
| SECONDARY Lissamine Green Staining: Inferior Temporal |
0.83; 0.76; 0.95 | — |
| SECONDARY Lissamine Green Staining: Superior Temporal |
0.76; 0.66; 0.76 | — |
| SECONDARY Lissamine Green Staining: Temporal |
0.88; 0.81; 0.93 | — |
| SECONDARY Lissamine Green Staining: Inferior Nasal |
0.92; 0.94; 1.11 | — |
| SECONDARY Lissamine Green Staining: Superior Nasal |
0.94; 0.86; 0.88 | — |
| SECONDARY Lissamine Green Staining: Nasal |
1.04; 0.93; 0.99 | — |
| SECONDARY Conjunctival Redness |
1.87; 1.87; 1.94 | — |
| SECONDARY Unanesthetized Schirmer's Test |
5.2; 5.0; 4.7 | — |
| SECONDARY Tear Film Break-up Time (TFBUT) |
2.598; 2.540; 2.441 | — |
| SECONDARY Ocular Surface Disease Index (OSDI): Subtotal 1-5 |
37.44; 37.71; 37.50 | — |
| SECONDARY Ocular Surface Disease Index (OSDI): Subtotal 6-9 |
39.29; 40.34; 35.75 | — |
| SECONDARY Ocular Surface Disease Index (OSDI): Subtotal 10-12 |
55.86; 49.26; 55.53 | — |
| SECONDARY Ocular Surface Disease Index (OSDI): Total |
42.49; 41.46; 41.42 | — |
| SECONDARY Burning/Stinging |
34.5; 37.9; 43.3 | — |
| SECONDARY Itching |
38.5; 44.2; 40.9 | — |
| SECONDARY Foreign Body Sensation |
38.8; 40.2; 40.6 | — |
| SECONDARY Blurred Vision |
41.2; 45.0; 41.5 | — |
| SECONDARY Eye Dryness |
61.2; 65.3; 60.4 | — |
| SECONDARY Photophobia |
44.9; 47.1; 44.0 | — |
| SECONDARY Pain in Eyes |
30.5; 28.2; 33.6 | — |
| SECONDARY Treatment Compliance Using a Daily Compliance Diary |
114.90; 100.13; 100.83 | — |
| SECONDARY Drop Comfort - Positive Response |
89.5; 84.7; 84.9 | — |
| SECONDARY Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR |
0; 0; 0 | — |
| SECONDARY Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS |
0; 0; 0 | — |
| SECONDARY Adverse Event Query - TEAEs |
21; 24; 31 | — |
| SECONDARY Adverse Event Query - Ocular TEAEs |
12; 13; 17 | — |
| SECONDARY Adverse Event Query - Non Ocular TEAEs |
11; 13; 18 | — |
| SECONDARY Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation |
3; 2; 1 | — |
| SECONDARY Adverse Event Query - TEAEs Suspected to be Related to Study Drug |
8; 5; 5; 2; 1; 4 | — |
| SECONDARY Adverse Event Query - SEA Reported |
1; 0; 1 | — |
| SECONDARY Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS |
0; 0; 0 | — |
| SECONDARY Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals eligible to participate in this study must meet all of the following criteria: 0. Be at least 18 years of age;
- Provide written informed consent;
- Be willing and able to comply with all study procedures;
- Have a patient-reported 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;
- 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;
- 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;
- 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;
- 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;
- 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®;
- 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);
- Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10 and 11 above;
- 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
- Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study: 0. Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- Have used Restasis®, Xiidra®, or Cequa®, Eysuvis™ and Tyrvaya™ within 60 days of Visit 1;
- 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;
- Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
- 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
- Oral aspirin or aspirin-containing prod
Data sourced from ClinicalTrials.gov (NCT05467293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.