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Dry EyePhase 3NCT07740564

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

A Phase 3 study testing OT202 conc 1% in people with Dry Eye, run by Ocumension Therapeutics (Suzhou) Co., Ltd at 49 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Dry Eye
What is being tested?
OT202 conc 1%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
842 participants
Where
49 sitesChina
Study dates
25 Aug 2026to May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 30 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:
  • 5 ≤ TCSS ≤ 15, with individual corneal region staining ≤ 3
  • Eye dryness score (EDS) ≥ 40 points in VAS
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  • TFBUT ≤ 5 seconds
  • 1 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.

Who cannot join

  • 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.
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  • 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.
  • Note: Non-periocular, low-potency, over-the-counter corticosteroid topical skin creams are allowed for use in the study (e.g., hydrocortisone butyrate cream/ointment).
  • Those who wore corneal contact lenses within 7 days prior to screening or required them during the study.
  • Those who underwent meibomian gland massage or moist chamber therapy within 7 days prior to screening, or non-drug therapies for dry eye such as intense pulsed light therapy, thermal pulsation therapy, etc., within the previous 6 months before screening.
  • Those who previously underwent dry eye surgery such as tear duct embolization (current tear duct embolization status or punctal plug use in the past 6 months) or amniotic membrane transplantation.
  • Those who underwent ocular surface surgery (e.g., LASIK excimer laser in situ keratomileusis) within 12 months prior to screening or intraocular surgery within 6 months prior to screening in either eye, as determined by the subject's medical history and/or examination, or anticipated ocular surgery during the study.
  • Those who use other investigational products or devices within 3 months prior to screening or concurrently during the study.
  • Non-compliance with drug administration (< 80% or > 120%) during the introduction period.
  • Females of childbearing potential who are currently pregnant, or have a positive pregnancy test result, or plan to get pregnant during the study, or are currently breastfeeding, or do not agree to use appropriate contraception methods to avoid pregnancy during the study period up to 1 month after the last dose of study drug.
  • Males who do not agree to use one or more acceptable effective contraception methods during the study period up to 1 month after the last dose of study drug.
  • Any condition or situation that, in the opinion of the investigator, may pose a safety risk to the subject in the trial or may interfere with the conduct of the study, or the investigator believes that the subject may not be able to complete or comply with the requirements of the study (due to administrative reasons or otherwise).

Trial locations and contacts

49 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Chen contact

0577-88075582

chenwei@eye.ac.cn

Jia Qu contact

0577-88068888

jia.qu@163.com

49 sites in 1 country

China49 sites, 49 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Mingwei Zhao

    Not yet recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Di Chen

    Not yet recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233004

    Ziqing Gao

    Not yet recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

    Hua Wang

    Not yet recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

    Zhihong Deng

    Not yet recruiting

  • Changsha Aier Eye Hospital

    Changsha, Hunan, 410015

    Kuanshu Li

    Not yet recruiting

  • Changzhou Third People's Hospital

    Changzhou, Jiangsu, 213001

    Songtao Yuan

    Not yet recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Jing Tang

    Not yet recruiting

  • Chongqing Aier Eye Hospital

    Chongqing, Chongqing Municipality, 400020

    Yi Ren

    Not yet recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

    Xiang Ma

    Not yet recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Limin Chen

    Not yet recruiting

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060 / 510623

    Saiqun Li

    Not yet recruiting

  • The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

    Guiyang, Guizhou, 550001

    Xianfeng Yao

    Not yet recruiting

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

    Haikou, Hainan, 570102

    Haisheng Zheng

    Not yet recruiting

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Xiuming Jin

    Not yet recruiting

  • Harbin No.242 Hospital

    Harbin, Heilongjiang, 150066

    Xiaomei Gou

    Not yet recruiting

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

    Dawei Sun

    Not yet recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Liming Tao

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Jianqiao Li

    Not yet recruiting

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

    Kunming, Yunnan, 650021

    Hai Liu

    Not yet recruiting

  • Nanjing Medical University Eye Hospital

    Nanjing, Jiangsu, 210029

    Jinsong Xue

    Not yet recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

    Qi Chen

    Not yet recruiting

  • Ningbo Eye Hospital

    Ningbo, Zhejiang, 315040

    Feng Wen

    Not yet recruiting

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, Shandong, 266011

    Yanling Dong

    Not yet recruiting

  • Shanghai Eye Disease Prevention and Treatment Center

    Shanghai, Shanghai Municipality, 200040

    Jiannan Huang

    Not yet recruiting

  • Tongren Hospital Shanghai Jiao Tong University School Of Medicine

    Shanghai, Shanghai Municipality, 200336

    Qinghua Qiu

    Not yet recruiting

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

    Shantou, Guangdong, 515041

    Di Ma

    Not yet recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Han Zhang

    Not yet recruiting

  • The Fourth People's Hospital of Shenyang

    Shenyang, Liaoning, 110031

    Tongtong Niu

    Not yet recruiting

  • Shenzhen Eye Hospital

    Shenzhen, Guangdong, 518040

    Ping Guo

    Not yet recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50000

    Danyan Liu

    Not yet recruiting

  • Shanxi Eye Hospital

    Taiyuan, Shanxi, 30002

    Xiaofen Zheng

    Not yet recruiting

  • Tianjin Eye Hospital

    Tianjin, Tianjin Municipality, 300020

    Luxia Chen

    Not yet recruiting

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin Municipality, 300384

    Hui Liu

    Not yet recruiting

  • Weifang Eye Hospital

    Weifang, Shandong, 261041

    Jibing Wang

    Not yet recruiting

  • Eye Hospital, WMU

    Wenzhou, Zhejiang, 325027

    Jia Qu

    Wei Chen

    Recruiting

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

    Wuhan, Hubei, 430022

    Mingchang Zhang

    Not yet recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Hongmei Zheng

    Not yet recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Min Ke

    Not yet recruiting

  • Xi'an NO.1 Hospital

    Xi'an, Shaanxi, 710002

    Yan Cheng

    Not yet recruiting

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

    Xi'an, Shaanxi, 710004

    Yong Li

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Li Li

    Not yet recruiting

  • Xiamen Eye Center Affiliated to Xiamen University

    Xiamen, Fujian, 361003

    Huping Wu

    Not yet recruiting

  • The First People's Hospital of Xuzhou

    Xuzhou, Jiangsu, 221000

    Suyan Li

    Not yet recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

    Fen Zhou

    Not yet recruiting

  • Yanbian University Hospital

    Yanji, Jilin, 133000

    Renzhe Cui

    Not yet recruiting

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, 750002

    Yan Zhu

    Not yet recruiting

  • Zhengzhou Second Hospital

    Zhengzhou, Henan, 450015

    Qian Wang

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Guangming Wan

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of OT202 Eye Drops in the Treatment of Moderate to Severe Dry Eye

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
Being tested
OT202 conc 1%, Placebo
Keywords
Moderate dry eye, Severe dry eye
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OT202 conc 1%Drug

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

  • PlaceboDrug

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

Study groups in NCT07740564
Study groupRoleWhat they receive
OT202 conc. 1% groupExperimentalAdministered three times daily, with 1-2 drops each time, instilled into the conjunctival sac.
Receives: Drug: OT202 conc 1%
Placebo groupExperimentalAdministered three times daily, with 1-2 drops each time, instilled into the conjunctival sac.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Corneal Fluorescein Staining (TCSS) score

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

    Measured: Day 56

  2. 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.

    Measured: Day 56

Secondary outcomes (5)

  1. Symptom assessment in dry eye (SANDE) scores

    Compare the between-group differences in the change from baseline for SANDE scores on Day 56

    Measured: Day 56

  2. Ocular surface disease index (OSDI) scores

    Compare the between-group differences in the change from baseline for OSDI scores on Day 56

    Measured: Day 56

  3. Corneal staining scores

    Compare the between-group differences in the change from baseline for corneal staining scores (including individual corneal zone scores and total corneal staining scores at Visits 3 and 4) at Visit 3 (Day 14), Visit 4 (Day 28), and Visit 5 (Day 56).

    Measured: Day 14\Day 28\Day 56

  4. Tear film break-up time (TFBUT)

    Compare the between-group differences in the change from baseline for TFBUT at Visit 3 (Day 14), Visit 4 (Day 28), and Visit 5 (Day 56).

    Measured: Day 14\Day 28\Day 56

  5. Schirmer I test

    Compare the between-group differences in the change from baseline for Schirmer I test at Visit 3 (Day 14), Visit 4 (Day 28), and Visit 5 (Day 56).

    Measured: Day 14\Day 28\Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2026
  2. Study start25 Aug 2026
  3. Primary completionJan 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment: 1% OT202 eye drop group; OT202 solvent eye drop group with a 1:1 ratio.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
842 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07740564
Sponsor's protocol ID
OT202-03-01
Status last verified
Jul 2026
First submitted
23 Jul 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OT202 conc 1% in people with Dry Eye, run by Ocumension Therapeutics (Suzhou) Co., Ltd at 49 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Chen (0577-88075582, chenwei@eye.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Corneal Fluorescein Staining (TCSS) score (time frame: Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07740564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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