Study of OT202 in Treating Moderate to Severe Dry Eye

NCT06435182 | Completed Phase 2

• 1 other identifier: OT202-02-01
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Dry Eye

Keywords

Moderate dry eye; Severe dry eye

Outcome Measures

Primary Outcomes (1)

• Total Corneal Fluorescein Staining (TCSS) score

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

  Day 56

Secondary Outcomes (7)

• Visual Analogue Scale (VAS) Score

  DAY 28 & 56

• Ocular Surface Disease Index (OSDI) Score

  Day 28 & 56

• Conjunctive Hyperemia

  Day 28 & 56

• Corneal Staining

  Day 28 & 56

• A dry eye syndrome questionnaire - Symptom Assessment iN Dry Eye(SANDE)

  Day 28 & 56

Study Arms (3)

OT202 conc.0.5% group

EXPERIMENTAL

Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.

Drug: OT202 conc 0.5%

OT202 conc. 0.1% group

EXPERIMENTAL

Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.

Drug: OT202 conc 0.1%

Placebo group

EXPERIMENTAL

Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.

Drug: Placebo

Interventions

OT202 conc 0.5% DRUG

Apply 1-2 drops of OT202 0.5% solution into the conjunctival sac. three times daily

Also known as: Investigational product

OT202 conc.0.5% group

OT202 conc 0.1% DRUG

Apply 1-2 drops of OT202 0.1% solution into the conjunctival sac. three times daily

Also known as: Investigational product

OT202 conc. 0.1% group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 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 ≥ 2 points
• Eye dryness score (EDS) ≥ 40 points in VAS
• Conjunctival hyperemia score ≥ 1 point
• 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:

• 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, 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 expected to potentially affect the study results. It include 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.
• 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).

Sponsors & Collaborators

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

Study Sites (10)

The Third Xiangya Hospital Of Central South University

Changsha, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Location

Then Second People's Hospital of Yunnan Province

Kunming, China

Location

Ning Bo Eye Hospital

Ningbo, China

Location

Tianjin Eye Hospital

Tianjin, China

Location

Tianjin Medical University Eye Hospital

Tianjin, China

Location

Eye Hospital, WMU

Wenzhou, China

Location

Renmin Hospital of Wuhan University

Wuhan, China

Location

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

Wuhan, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: 0.5% OT202 eye drop group；1% OT202 eye drop group；OT202 solvent eye drop group with a 1:1:1 ratio.

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: April 10, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)