Study of OT202 in Treating Moderate to Severe Dry Eye

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Drug: Placebo; Drug: OT202 conc 0.1%; Drug: OT202 conc 0.5%

• Registration Number: NCT06435182
• Lead Sponsor: Ocumension Therapeutics (Shanghai) Co., Ltd

Brief Summary

This is a phase II study to explore the optimal dosage of OT202 in treating dry eye.

Detailed Description

Subjects successfully enrolled will enter a 2-week induction period of OT202 solvent eye drops, treated with OT202 three times daily (morning, afternoon, and evening), with 1-2 drops each time. On the day of the baseline visit (Visit 2), subjects will be assessed again to meet the inclusion and exclusion criteria. Subjects remain in the study are then randomized with a 1:1:1 ratio to 3 groups, the 0.5% OT202 eye drop group, 1% OT202 eye drop group, or OT202 solvent eye drop group, for an 8-week treatment period. Safety visits will be conducted 2 weeks after completion of the respective treatment.

Study Timeline

• Study Start: 2023-04-10
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Status Verified: 2024-05
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-30
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
OT202 conc. 0.1% group	OT202 conc 0.1%	Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
OT202 conc.0.5% group	OT202 conc 0.5%	Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.

Primary Outcome Measures

Name	Time	Method
Total Corneal Fluorescein Staining (TCSS) score	Day 56	Compare the difference of changes in TCSS relative to baseline of three study groups on day 56.

Secondary Outcome Measures

Name	Time	Method
Tear Film Breakup-time (TFBUT)	Day 28 & 56	Compare the DAY 28 \& 56 TFBUT scale results of the subjects with baseline .
Visual Analogue Scale (VAS) Score	DAY 28 & 56	Compare the difference of changes in VAS scale relative to baseline of three study groups on day 28 \& 56.
Schirmer I Test	Day 28 & 56	Compare the DAY 28 \& 56 Schirmer I Test scale results of the subjects with baseline .
Ocular Surface Disease Index (OSDI) Score	Day 28 & 56	Compare the DAY 28 \& 56 OSDI scale results of the subjects with the baseline results.
Conjunctive Hyperemia	Day 28 & 56	Compare the DAY 28 \& 56 Conjunctive Hyperemia data of the subjects with the baseline data.
Corneal Staining	Day 28 & 56	Compare the DAY 28 \& 56 Corneal Staining data of the subjects with the baseline data.
A dry eye syndrome questionnaire - Symptom Assessment iN Dry Eye(SANDE)	Day 28 & 56	Compare the DAY 28 \& 56 SANDE scale results of the subjects with baseline .

Trial Locations

Locations (10)

The Third Xiangya Hospital Of Central South University; 🇨🇳 Changsha, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Tianjin Eye Hospital; 🇨🇳 Tianjin, China

Then Second People's Hospital of Yunnan Province; 🇨🇳 Kunming, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, China

Ning Bo Eye Hospital; 🇨🇳 Ningbo, China

Tianjin Medical University Eye Hospital; 🇨🇳 Tianjin, China

Eye Hospital, WMU; 🇨🇳 Wenzhou, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China