NCT05467293

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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Yuyu Pharma, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Dry Eye

Interventions

Type	Name	Description
DRUG	0.3% YP-P10 Ophthalmic Solution	Drug: YP-P10 Ophthalmic Solution
DRUG	1% YP-P10 Ophthalmic Solution	Drug: YP-P10 Ophthalmic Solution
DRUG	YP-P10 Placebo Ophthalmic Solution (vehicle)	Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Timeline

• Start date: 2022-06-27
• Primary completion: 2023-03-06
• Completion: 2023-03-06
• First posted: 2022-07-20
• Last updated: 2024-07-30
• Results posted: 2024-07-30

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study