Phase III Study of OT202 in Treating Moderate to Severe Dry Eye

NCT07740564 | Not Yet Recruiting Phase 3

• 1 other identifier: OT202-03-01
• Study Type: interventional
• Target: 842
• Locations: 1 country
• Sites: 49

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, enrolling 842 subjects with moderate to severe dry eye, who will be randomized at a 1:1 ratio to receive either 1% OT202 ophthalmic solution or vehicle control. The trial consists of screening, run-in, 8-week double-blind treatment period, and three long-term safety follow-up cohorts (10 weeks, 28 weeks, and 54 weeks), including 342 subjects for the 10-week follow-up, 350 subjects for the 28-week follow-up, and 150 subjects for the 54-week follow-up. Unblinding will be performed after the completion of double-blind treatment for all subjects, who will then receive open-label 1% OT202 ophthalmic solution uniformly. The co-primary efficacy endpoints are the change from baseline in Total Corneal Fluorescein Staining Score (TCSS) and Visual Analog Scale-Eye Dryness Score (VAS-EDS) at Day 56. Pharmacokinetic assessments will be conducted in 60 of the subjects assigned to the 54-weeks long-term safety follow-up. An interim futility analysis will be performed once approximately 30% of subjects complete the treatment period. Analysis of covariance (ANCOVA) will be utilized for efficacy statistical analyses. The primary objective is to evaluate the efficacy and safety of OT202 ophthalmic solution in the treatment of moderate to severe dry eye.

Conditions

Dry Eye

Keywords

Moderate dry eye; Severe dry eye

Outcome Measures

Primary Outcomes (2)

• Total Corneal Fluorescein Staining (TCSS) score

  Compare the difference of changes in TCSS relative to baseline of two study groups on day 56.

  Day 56

• Total visual analogue scale (VAS)-eye dryness score (EDS) score

  Compare the between-group differences in the change from baseline for total VAS-EDS score on Day 56.

  Day 56

Secondary Outcomes (5)

• Symptom assessment in dry eye (SANDE) scores

  Day 56

• Ocular surface disease index (OSDI) scores

  Day 56

• Corneal staining scores

  Day 14\Day 28\Day 56

• Tear film break-up time (TFBUT)

  Day 14\Day 28\Day 56

• Schirmer I test

  Day 14\Day 28\Day 56

Study Arms (2)

OT202 conc. 1% group

EXPERIMENTAL

Administered three times daily, with 1-2 drops each time, instilled into the conjunctival sac.

Drug: OT202 conc 1%

Placebo group

EXPERIMENTAL

Administered three times daily, with 1-2 drops each time, instilled into the conjunctival sac.

Drug: Placebo

Interventions

OT202 conc 1% DRUG

Apply 1-2 drops of OT202 1% solution into the conjunctival sac. three times daily

OT202 conc. 1% group

Placebo DRUG

Apply 1-2 drops of placebo solution into the conjunctival sac. three times daily

Placebo group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of age (inclusive) at the time of signing the ICF, either sex or ethnic group.
• With history of dry eye for at least 6 months prior to screening, and history of use or willingness to use eye drops for the treatment of dry eye within 6 months prior to screening.
• Binocular BCVA ≥ 0.25 decimals (standard logarithmic visual acuity chart) at Screening and Baseline.
• At least one eye (the same eye) meets all the following criteria at screening and baseline:
• ≤ TCSS ≤ 15, with individual corneal region staining ≤ 3
• Eye dryness score (EDS) ≥ 40 points in VAS
• TFBUT ≤ 5 seconds
• mm/5 min ≤ Schirmer I test (without surface anesthesia) ≤ 10 mm/5 min
• Must be able to understand and sign the ICF approved by Independent Ethics Committee (EC).
• Willing and able to conduct protocol-required study visits, follow study guidelines, and take study drug as instructed.

You may not qualify if:

• Patients who have previously participated in a Phase I or Phase II clinical study of OT202
• With contraindication or hypersensitivity to the study drug (OT202 and excipients) or diagnostic reagents (fluorescein sodium, lissamine green, etc.).
• During the screening period and baseline period, any eye with ocular active inflammation or structural abnormalities that may affect the trial assessment, including but not limited to trichiasis, blepharospasm, blepharitis, meibomitis, severe meibomian gland dysfunction(diagnosed according to the Expert Consensus on the Diagnosis and Treatment of Meibomian Gland Dysfunction in China (2023)), bulbar conjunctival laxity, keratitis, recurrent corneal erosion, allergic conjunctivitis, iritis, anterior chamber inflammation, known retinal detachment, diabetic retinopathy, or history of any progressive retinal disease.
• With history of possible or confirmed ocular infection (bacterial, viral, or fungal) or ocular herpes (simple or zoster) in either eye, as determined by the patient's medical history and/or at the screening and baseline examinations.
• Those with intraocular pressure (non-contact tonometry) greater than 21 mmHg or less than 8 mmHg or diagnosed with glaucoma at screening and baseline, or those with ocular hypertension who underwent intraocular pressure reduction therapy, and those with a history or suspicion of glaucoma.
• Those with any systemic disease are expected to potentially affect the study results. It includes but is not limited to Sjögren syndrome, Stevens-Johnson syndrome, rheumatoid arthritis, graft versus host disease, systemic lupus erythematosus, scleroderma, sarcoidosis, herpes, acne, rosacea, etc.
• Those who cannot stop using any ocular medication or treatment during the clinical trial.
• Those with recent clinically relevant history (e.g., hepatic, renal impairment) within 6 months prior to screening or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune, and other relevant systemic diseases (e.g., severe chronic obstructive pulmonary disease, arrhythmia, significant heart failure, uncontrolled hypertension, type 2 diabetes mellitus), as assessed by the investigator.
• Those on a chronic, systemic medication regimen used for less than 1 month at screening and baseline or with dose changed within 1 month (including initiation of new medication and discontinuation).
• Those who have used any prohibited medications (topical ocular, systemic, and/or injectable medications) during the specified period prior to screening. These medications are also prohibited during the study. However, if a subject has a prohibited medication at screening, it needs to be stopped and washed out according to the washout period specified below, which can be included in the wash-out period. The minimum reasonable washout period for prohibited medications is as follows:
• Systemic and local immunosuppressant and immunotherapy (such as cyclosporine eye drops, tacrolimus eye drops, etc.): 60 days;
• Corticosteroids (any route): 14 days;
• Systemic or ocular topical mast cell stabilizers, antihistamines, antihistamines/mast cell stabilizer combination, vasoconstrictors, monoamine oxidase inhibitors: 7 days;
• Other topical ophthalmic preparations (including artificial tears): 3 days;
• Medications known to cause ocular dryness (e.g., anticholinergics, serotonin reuptake inhibitors, beta-blockers, diuretics, etc.): 14 days.

Sponsors & Collaborators

• Ocumension Therapeutics (Suzhou) Co., Ltd: lead

Study Sites (49)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Chongqing Aier Eye Hospital

Chongqing, Chongqing Municipality, 400020, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Xiamen Eye Center Affiliated to Xiamen University

Xiamen, Fujian, 361003, China

Location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060 / 510623, China

Location

Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, Guangdong, 515041, China

Location

Shenzhen Eye Hospital

Shenzhen, Guangdong, 518040, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Guiyang, Guizhou, 550001, China

Location

Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University

Haikou, Hainan, 570102, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 50000, China

Location

Harbin No.242 Hospital

Harbin, Heilongjiang, 150066, China

Location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Zhengzhou Second Hospital

Zhengzhou, Henan, 450015, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Changsha Aier Eye Hospital

Changsha, Hunan, 410015, China

Location

Changzhou Third People's Hospital

Changzhou, Jiangsu, 213001, China

Location

Nanjing Medical University Eye Hospital

Nanjing, Jiangsu, 210029, China

Location

The First People's Hospital of Xuzhou

Xuzhou, Jiangsu, 221000, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Yanbian University Hospital

Yanji, Jilin, 133000, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

The Fourth People's Hospital of Shenyang

Shenyang, Liaoning, 110031, China

Location

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750002, China

Location

Xi'an NO.1 Hospital

Xi'an, Shaanxi, 710002, China

Location

Xi'an People's Hospital (Xi'an Fourth Hospital

Xi'an, Shaanxi, 710004, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Qingdao Eye Hospital of Shandong First Medical University

Qingdao, Shandong, 266011, China

Location

Weifang Eye Hospital

Weifang, Shandong, 261041, China

Location

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location

Tongren Hospital Shanghai Jiao Tong University School Of Medicine

Shanghai, Shanghai Municipality, 200336, China

Location

Shanxi Eye Hospital

Taiyuan, Shanxi, 30002, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300384, China

Location

Affiliated Hospital of Yunnan University (The Second People's Hospital of Yunnan Province / Yunnan Eye Hospital)

Kunming, Yunnan, 650021, China

Location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Ningbo Eye Hospital

Ningbo, Zhejiang, 315040, China

Location

Eye Hospital, WMU

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Wei Chen

  Eye Hospital, WMU

  PRINCIPAL INVESTIGATOR

• Jialu Xia

  Sponsor GmbH

  STUDY DIRECTOR

Central Study Contacts

Wei Chen

CONTACT

0577-88075582; chenwei@eye.ac.cn

Jia Qu

CONTACT

0577-88068888; jia.qu@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment: 1% OT202 eye drop group; OT202 solvent eye drop group with a 1:1 ratio.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (49)