Can a new eye drop soothe severe dry eye?

NCT ID NCT07740564

Disease control Sponsor: Ocumension Therapeutics (Suzhou) Co., Ltd Source: ClinicalTrials.gov ↗

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This clinical trial is testing whether an experimental eye drop called OT202 can improve symptoms and repair the eye surface in people with moderate to severe dry eye. About 842 adults aged 30 to 75 with a history of dry eye will receive either OT202 or a placebo drop three times a day for 8 weeks. The study will measure changes in eye dryness and corneal damage, and will also track long-term safety over up to 54 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: OT202 ophthalmic solution (1%)
What this could lead to: If successful, OT202 eye drops could offer a new treatment option to relieve dryness and repair the eye surface in people with moderate to severe dry eye.
What could go wrong: This is a Phase 3 trial, but results are not guaranteed. The treatment may not prove more effective than placebo, and long-term safety is still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 842 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 30 to 75 years of age (inclusive) at the time of signing the ICF, either sex or ethnic group. 2. 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. 3. Binocular BCVA ≥ 0.25 decimals (standard logarithmic visual acuity chart) at Screening and Baseline. 4. 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 * TFBUT ≤ 5 seconds * 1 mm/5 min ≤ Schirmer I test (without surface anesthesia) ≤ 10 mm/5 min 5. Must be able to understand and sign the ICF approved by Independent Ethics Committee (EC). 6. Willing and able to conduct protocol-required study visits, follow study guidelines, and take study drug as instructed. Exclusion Criteria: 1. Patients who have previously participated in a Phase I or Phase II clinical study of OT202 2. With contraindication or hypersensitivity to the study drug (OT202 and excipients) or diagnostic reagents (fluorescein sodium, lissamine green, etc.). 3. 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. 4. 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. 5. 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. 6. 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. 7. Those who cannot stop using any ocular medication or treatment during the clinical trial. 8. 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. 9. 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). 10. 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). 11. Those who wore corneal contact lenses within 7 days prior to screening or required them during the study. 12. 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. 13. 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. 14. 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. 15. Those who use other investigational products or devices within 3 months prior to screening or concurrently during the study. 16. Non-compliance with drug administration (\< 80% or \> 120%) during the introduction period. 17. 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. 18. 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. 19. 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).

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

49 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

Kunming, Yunnan, 650021, China
Changsha Aier Eye Hospital

Changsha, Hunan, 410015, China
Changzhou Third People's Hospital

Changzhou, Jiangsu, 213001, China
Chongqing Aier Eye Hospital

Chongqing, Chongqing Municipality, 400020, China
Eye Hospital, WMU

Wenzhou, Zhejiang, 325027, China
Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University

Haikou, Hainan, 570102, China
Harbin No.242 Hospital

Harbin, Heilongjiang, 150066, China
Nanjing Medical University Eye Hospital

Nanjing, Jiangsu, 210029, China
Ningbo Eye Hospital

Ningbo, Zhejiang, 315040, China
Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China
Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China
People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750002, China
Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China
Qingdao Eye Hospital of Shandong First Medical University

Qingdao, Shandong, 266011, China
Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China
Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 200040, China
Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, Guangdong, 515041, China
Shanxi Eye Hospital

Taiyuan, Shanxi, 30002, China
Shenzhen Eye Hospital

Shenzhen, Guangdong, 518040, China
The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China
The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China
The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China
The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Guiyang, Guizhou, 550001, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China
The First People's Hospital of Xuzhou

Xuzhou, Jiangsu, 221000, China
The Fourth People's Hospital of Shenyang

Shenyang, Liaoning, 110031, China
The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China
The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China
The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China
The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 50000, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China
Tianjin Eye Hospital

Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300384, China
Tongren Hospital Shanghai Jiao Tong University School Of Medicine

Shanghai, Shanghai Municipality, 200336, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China
Weifang Eye Hospital

Weifang, Shandong, 261041, China
West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China
Xi'an NO.1 Hospital

Xi'an, Shaanxi, 710002, China
Xi'an People's Hospital (Xi'an Fourth Hospital

Xi'an, Shaanxi, 710004, China
Xiamen Eye Center Affiliated to Xiamen University

Xiamen, Fujian, 361003, China
Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China
Yanbian University Hospital

Yanji, Jilin, 133000, China
Zhengzhou Second Hospital

Zhengzhou, Henan, 450015, China
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China
Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060 / 510623, China

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