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

ConditionDry Eye
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-75
SponsorOcumension Therapeutics (Suzhou) Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

5 ≤ TCSS ≤ 15, with individual corneal region staining ≤ 3

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • OT202 conc 1%

    Drug

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

  • Placebo

    Drug

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

Treatment groups

842 Participants
are divided into 2 treatment groups
Group A: OT202 conc. 1% groupExperimental treatment 1 intervention
Group B: Placebo groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total Corneal Fluorescein Staining (TCSS) score

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

Time frame
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.

Time frame
Day 56

Secondary outcomes

1

Symptom assessment in dry eye (SANDE) scores

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

Time frame
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

Time frame
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).

Time frame
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).

Time frame
Day 14\Day 28\Day 56

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ocumension Therapeutics (Suzhou) Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: