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Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03676335
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Brief Summary:
The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe tear deficiency dry eye with different dosage, frequency and concentration, and to preliminarily determine the optimal dosage, frequency and concentration, so as to provide a theoretical basis for the design of follow-up clinical studies.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: CsA eye gel Drug: CsA for eye emulsion Drug: Hypromellose Eye Drops Phase 2

Detailed Description:

A multicenter, randomized, single-blind, positive controlled exploratory study will be conducted with cyclosporine A ophthalmic emulsion as the control drug.

The experimental drugs were divided into three groups:

Treatment group A: CsA eye gel: 0.3 g: 0.15 mg, once daily; Treatment group B: CsA eye gel: 0.3 g: 0.15 mg, twice daily, interval of about 12 hours; Treatment group C: CsA eye gel: 0.3 g: 0.3 mg, once daily. One drop into each eye when you use it.

Control group: CsA emulsion: 0.4 ml: 0.2 mg. One drop into the eye, 2 times daily with an interval for 12 hours.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Ⅱ, Multicenter, Randomized, Single-blind, Positive-controlled, Dose-finding Study to Assess the Efficacy and Safety of CsA Ophthalmic Gel in Subjects With Moderate to Severe Aqueous-Deficient Dry Eye (ADDE)
Actual Study Start Date : May 9, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : December 12, 2019

Arm Intervention/treatment
Experimental: 0.3 g: 0.15 mg(1)&Hypromellose Eye Drops
Sixty 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 eye gel
The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
Other Name: CsA gel

Drug: Hypromellose Eye Drops
Hypromellose Eye Drops of 15ml:75mg, 3 times daily, 1-2 drop
Other Name: zhenshishuang

Experimental: 0.3 g: 0.15mg(2)&Hypromellose Eye Drops
Sixty subjects will be treated with CsA eye gel: 0.3 g: 0.15 mg, 2 times daily, interval of about 12 hours, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Drug: CsA eye gel
The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
Other Name: CsA gel

Drug: Hypromellose Eye Drops
Hypromellose Eye Drops of 15ml:75mg, 3 times daily, 1-2 drop
Other Name: zhenshishuang

Experimental: 0.3 g: 0.3 mg &Hypromellose Eye Drops
Sixty subjects will be treated with CsA eye gel: 0.3 g: 0.3 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 eye gel
The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
Other Name: CsA gel

Drug: Hypromellose Eye Drops
Hypromellose Eye Drops of 15ml:75mg, 3 times daily, 1-2 drop
Other Name: zhenshishuang

Active Comparator: 0.4 ml: 0.2 mg &Hypromellose Eye Drops
Sixty subjects will be treated with CsA for eye emulsion: 0.4 ml: 0.2 mg, 2 times daily, interval of about 12 hours, The treatment period is 12 weeks. The basic medicine is Hypromellose Eye Drops, 3 times daily for 12 weeks.
Drug: CsA for eye emulsion
The CsA for eye emulsion of 0.4 ml: 0.2 mg
Other Name: CsA emulsion

Drug: Hypromellose Eye Drops
Hypromellose Eye Drops of 15ml:75mg, 3 times daily, 1-2 drop
Other Name: zhenshishuang




Primary Outcome Measures :
  1. The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular) [ Time Frame: 84 days after admission ]
    0-100 points VAS score was evaluated


Secondary Outcome Measures :
  1. The EDS score at the NO.3, NO.4 visit were compared with the baseline EDS score (binocular) [ Time Frame: 14 days after admission ,42days after admission ]
    0-100 points VAS score was evaluated

  2. 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

  3. Comparison of the NO.3, NO.4, NO.5 visit and baseline corneal fluorescein staining changes [ Time Frame: 14 days after admission ,42 days after admission ,84 days after admission ]
    score(The cornea was divided into five quadrants: central, upper, lower, temporal and nasal. The cornea was stained with 4 points, 0 points for non-staining, 1 point for scattered dotted staining, 2 points for clan staining, 3 points for local dense + scattered dotted staining and 4 points for extensive diffuse staining. The total score is the sum of the quadrant scores)

  4. Comparison of the NO.3, NO.4, NO.5 visit and baseline BUT changes [ Time Frame: 14 days after admission ,42 days after admission ,84 days after admission ]
    time

  5. Comparison of the NO.3, NO.4, NO.5 visit and baseline Schirmer changes [ Time Frame: 14 days after admission ,42 days after admission ,84 days after admission ]
    Basal tear secretion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18, both male and female;
  2. Pregnancy tests were negative for women of childbearing age and contraceptive measures (including abstinence, intrauterine devices, diaphragms and spermicides) were taken during the trial. Men are willing to use approved contraceptive methods (possibly using condoms and spermicides or oral contraceptives, implants or injections of contraceptives, intrauterine devices, diaphragms and spermicides) or sexual partner infertility;
  3. 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. In any area, corneal fluorescein staining was more than 2 points.
  4. The anatomy of the eyelids is normal and has normal blinking function;
  5. Patients with newly diagnosed dry eye disease, or who are undergoing dry eye treatment, voluntarily discontinue treatment within 72 hours of entering the screening period;
  6. Ability and willingness to participate in all research assessments and all planned visits during the pilot period in accordance with the programme requirements;
  7. Agree to participate in the study and voluntarily sign informed consent.

Exclusion Criteria:

  1. Allergy to CsA, fluorescein or any component of the drug is known;
  2. Severe dry eye patients requiring surgical treatment;
  3. Glaucoma patients;
  4. Unwilling to avoid wearing contact lenses;
  5. Within 12 months prior to the start of the study, intraocular surgery or internal surgery was necessary;
  6. Eyelid surgery was performed within 6 months prior to the start of the study, or dry eye secondary to surgery;
  7. Those who had undergone corneal refractive surgery or keratoplasty;
  8. Congenital lacrimal gland or meibomian gland deficiency or lacrimal gland obstructive diseases;
  9. Systemic inflammation or active eye infection and blepharitis;
  10. Patients with ocular cicatricial pemphigoid, obvious conjunctival scar, ocular chemical burn and neurotrophic keratoconjunctivitis;
  11. Who suffered from ocular malignancies;
  12. No other eye drops could be stopped during the study period;
  13. Systemic or uncontrollable disorders that affect the collection of research parameters or patient compliance, such as severe cardiopulmonary disease, uncontrollable hypertension and diabetes;
  14. With history of central nervous system disease or epilepsy, and / or mental disorder;
  15. Pregnant women and lactating women, or women of childbearing age, do not adopt effective contraceptive measures;
  16. Participated in other clinical trials or participated in other clinical trials within 1 months before the election;
  17. Systemic or topical cyclosporine drugs within 3 months;
  18. Patients who were not considered suitable for the study, including those who were unable or unwilling to comply with the protocol requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676335


Locations
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China, Guangdong
Ophthalmological Center of Zhongshan University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Investigators
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Study Director: shiyou zhou, PHD Ophthalmological Center of Zhongshan University

Publications of Results:
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Responsible Party: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT03676335    
Other Study ID Numbers: ZK-CSA-201704
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions