Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease

April 21, 2022 updated by: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Efficacy and Safety Study of CsA Ophthalmic Gel in Subjects With Moderate to Severe Dry Eye Disease

The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe dry eye disease .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicenter,randomized, double-blind, vehicle-controlled Study.Subjects will be randomly assigned to the experimental group and the control group,experimental group: CsA eye gel: 0.3 g: 0.15 mg, once daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a day Control group: vehicle. One drop into the eye, once daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a day

Study Type

Interventional

Enrollment (Actual)

644

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Ophthalmological Center of Zhongshan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1）18≤Age≤80, both male and female 2）According to the symptoms and signs and ophthalmologic examinations, the patients were diagnosed as moderate to severe dry eye

  1. EDS score is more than 40 points;
  2. BUT is less than 10 s;
  3. Schirmer test result is less than 10mm/5 min;
  4. ICSS≥2 points. 3）The ICSS score of baseline decreased by≤ 20% compared with that of screening period 4）Agree to participate in the study and voluntarily sign informed consent.

Exclusion Criteria:

  1. Severe dry eye patients requiring surgical treatment
  2. Had inner eye surgery within 12 months prior to screening or required inner eye surgery during the study period;Eyelid surgery was performed within 6 months prior to screening
  3. Patients receiving permanent lacrimal insertion or patients receiving temporary lacrimal insertion within 6 months prior to screening;
  4. Operation-induced dry eye
  5. Glaucoma patients;
  6. Unwilling to avoid wearing contact lenses;
  7. Systemic inflammation or active eye infection and blepharitis;
  8. Patients with multiple episodes of viral keratitis
  9. Patients with ocular cicatricial pemphigoid, obvious conjunctival scar, ocular chemical burn and neurotrophic keratoconjunctivitis
  10. Patients with malignant tumors in the past 5 years, except the thoroughly cured basal cell carcinoma of skin, squamous cell carcinoma in situ of skin, and primordial cervical cancer;
  11. Perimenopausal women are taking hormone replacement therapy
  12. Patients who cannot stop using other eye drops and other ophthalmic preparations during the study period;
  13. Patients with severe cardiopulmonary diseases, uncontrolled hypertension and diabetes, etc. that affect the collection or compliance of study parameters;
  14. ALT and AST ≥ 2 times of the normal upper limit, and serum creatinine ≥ 1.5 times of the normal upper limit
  15. With a history of central nervous system disease or epilepsy, and/or a mental state that does not cooperate
  16. Pregnant women and lactating women, or women of childbearing age, do not adopt effective contraceptive measures;
  17. Participated in other clinical trials or participated in other clinical trials within 1 months before the election;
  18. Systemic or topical cyclosporine drugs within 1 months before the election;
  19. Allergy to CsA, fluorescein or any component of the drug is known；
  20. Patients who were not considered suitable for the study, including those who were unable or unwilling to comply with the protocol requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
322 subjects will be treated with CsA eye gel: 0.3 g: 0.15 mg, 1 times daily, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Drug: CsA Ophthalmic Gel
The CsA eye gel of 0.3 g: 0.15 mg
Other Names:
  • CsA gel
Drug: Hypromellose Eye Drop
Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop
Other Names:
  • zhenshishuang
Placebo Comparator: Control group
322 subjects will be treated with Placebo : 0 g: 0mg, 1 times daily, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Drug: Placebo
Placebo
Drug: Hypromellose Eye Drop
Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop
Other Names:
  • zhenshishuang

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients whose corneal fluorescein staining score (ICSS) decreased by ≥1 point from baseline at visit 5 (study eye)
Time Frame: 84 days after admission
ICSS：no staining = 0，few/rare punctate lesions = 1，discrete and countable lesions = 2，lesions too numerous to count，but not coalescent = 3，coalescent = 4
84 days after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDS score at the NO.3, NO.4 and NO.5 visit was compared with the baseline EDS score (binocular)
Time Frame: 14 days after admission ，42 days after admission ，84days days after admission
0-100 points VAS score was evaluated
14 days after admission ，42 days after admission ，84days days after admission
Average changes in VAS scores of 6 dry eye symptoms (burning/needling sensation, pruritus, foreign body sensation, discomfort, photophobia and pain) at the NO.3, NO.4 and NO.5 visit were compared with baseline (binocular)
Time Frame: 14 days after admission ，42 days after admission ，84days days after admission
0-100 points VAS score was evaluated
14 days after admission ，42 days after admission ，84days days after admission
corneal fluorescein staining score (ICSS)at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular)
Time Frame: 14 days after admission ，42 days after admission ，84days days after admission
ICSS：no staining = 0，few/rare punctate lesions = 1，discrete and countable lesions = 2，lesions too numerous to count，but not coalescent = 3，coalescent = 4
14 days after admission ，42 days after admission ，84days days after admission
oxford score at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular)
Time Frame: 14 days after admission ，42 days after admission ，84days days after admission
0~V grade was evaluated
14 days after admission ，42 days after admission ，84days days after admission
Tear break-up time(BUT) at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular)
Time Frame: 14 days after admission，42 days after admission ，84days days after admission
The time taken for the first dry spot to appear on the cornea after a complete blink with fluorescein
14 days after admission，42 days after admission ，84days days after admission
Schirmer's II test (with anesthetic) at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular)
Time Frame: 14 days after admission ，42 days after admission ，84days days after admission
Basal tear secretion with topical anesthesia, determined by the moisture length on the filter paper in 5 minutes
14 days after admission ，42 days after admission ，84days days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Investigators

  • Study Director: shiyou zhou, PHD, Ophthalmological Center of Zhongshan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Actual)

August 16, 2021

Study Completion (Actual)

October 14, 2021

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

September 7, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZKY-CSA-202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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