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

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

CsA eye gel

CsA for eye emulsion

Hypromellose Eye Drops

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18, both male and female;
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;
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.
The anatomy of the eyelids is normal and has normal blinking function;
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;
Ability and willingness to participate in all research assessments and all planned visits during the pilot period in accordance with the programme requirements;
Agree to participate in the study and voluntarily sign informed consent.

Exclusion Criteria:

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

Sites / Locations

Ophthalmological Center of Zhongshan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

0.3 g: 0.15 mg（1)&Hypromellose Eye Drops

0.3 g: 0.15mg（2)&Hypromellose Eye Drops

0.3 g: 0.3 mg &Hypromellose Eye Drops

0.4 ml: 0.2 mg &Hypromellose Eye Drops

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular)

0-100 points VAS score was evaluated

Secondary Outcome Measures

The EDS score at the NO.3, NO.4 visit were compared with the baseline EDS score (binocular)

0-100 points VAS score was evaluated

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)

0-100 points VAS score was evaluated

Comparison of the NO.3, NO.4, NO.5 visit and baseline corneal fluorescein staining changes

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）

Comparison of the NO.3, NO.4, NO.5 visit and baseline BUT changes

time

Comparison of the NO.3, NO.4, NO.5 visit and baseline Schirmer changes

Basal tear secretion

Full Information

NCT ID

NCT03676335

First Posted

August 30, 2018

Last Updated

May 6, 2020

Sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03676335

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

May 9, 2018 (Actual)

Primary Completion Date

June 30, 2019 (Actual)

Study Completion Date

December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.3 g: 0.15 mg（1)&Hypromellose Eye Drops

Arm Type

Experimental

Arm Description

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.

Arm Title

0.3 g: 0.15mg（2)&Hypromellose Eye Drops

Arm Type

Experimental

Arm Description

Arm Title

0.3 g: 0.3 mg &Hypromellose Eye Drops

Arm Type

Experimental

Arm Description

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.

Arm Title

0.4 ml: 0.2 mg &Hypromellose Eye Drops

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

CsA eye gel

Other Intervention Name(s)

CsA gel

Intervention Description

The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg

Intervention Type

Drug

Intervention Name(s)

CsA for eye emulsion

Other Intervention Name(s)

CsA emulsion

Intervention Description

The CsA for eye emulsion of 0.4 ml: 0.2 mg

Intervention Type

Drug

Intervention Name(s)

Hypromellose Eye Drops

Other Intervention Name(s)

zhenshishuang

Intervention Description

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

Primary Outcome Measure Information:

Title

The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular)

Description

0-100 points VAS score was evaluated

Time Frame

84 days after admission

Secondary Outcome Measure Information:

Title

The EDS score at the NO.3, NO.4 visit were compared with the baseline EDS score (binocular)

Description

0-100 points VAS score was evaluated

Time Frame

14 days after admission ，42days after admission

Title

Description

0-100 points VAS score was evaluated

Time Frame

14 days after admission ，42 days after admission ，84days days after admission

Title

Comparison of the NO.3, NO.4, NO.5 visit and baseline corneal fluorescein staining changes

Description

Time Frame

14 days after admission ，42 days after admission ，84 days after admission

Title

Comparison of the NO.3, NO.4, NO.5 visit and baseline BUT changes

Description

time

Time Frame

14 days after admission ，42 days after admission ，84 days after admission

Title

Comparison of the NO.3, NO.4, NO.5 visit and baseline Schirmer changes

Description

Basal tear secretion

Time Frame

14 days after admission ，42 days after admission ，84 days after admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18, both male and female; 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; According to the symptoms and signs and ophthalmologic examinations, the patients were diagnosed as moderate to severe dry eye; EDS score is more than 40 points; BUT is less than 10 s; Schirmer test result is less than 10mm/5 min; In any area, corneal fluorescein staining was more than 2 points. The anatomy of the eyelids is normal and has normal blinking function; 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; Ability and willingness to participate in all research assessments and all planned visits during the pilot period in accordance with the programme requirements; Agree to participate in the study and voluntarily sign informed consent. Exclusion Criteria: Allergy to CsA, fluorescein or any component of the drug is known; Severe dry eye patients requiring surgical treatment; Glaucoma patients; Unwilling to avoid wearing contact lenses; Within 12 months prior to the start of the study, intraocular surgery or internal surgery was necessary; Eyelid surgery was performed within 6 months prior to the start of the study, or dry eye secondary to surgery; Those who had undergone corneal refractive surgery or keratoplasty; Congenital lacrimal gland or meibomian gland deficiency or lacrimal gland obstructive diseases; Systemic inflammation or active eye infection and blepharitis; Patients with ocular cicatricial pemphigoid, obvious conjunctival scar, ocular chemical burn and neurotrophic keratoconjunctivitis; Who suffered from ocular malignancies; No other eye drops could be stopped during the study period; Systemic or uncontrollable disorders that affect the collection of research parameters or patient compliance, such as severe cardiopulmonary disease, uncontrollable hypertension and diabetes; With history of central nervous system disease or epilepsy, and / or mental disorder; Pregnant women and lactating women, or women of childbearing age, do not adopt effective contraceptive measures; Participated in other clinical trials or participated in other clinical trials within 1 months before the election; Systemic or topical cyclosporine drugs within 3 months; Patients who were not considered suitable for the study, including those who were unable or unwilling to comply with the protocol requirements.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

shiyou zhou, PHD

Organizational Affiliation

Ophthalmological Center of Zhongshan University

Official's Role

Study Director

Facility Information:

Facility Name

Ophthalmological Center of Zhongshan University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20735287

Citation

Utine CA, Stern M, Akpek EK. Clinical review: topical ophthalmic use of cyclosporin A. Ocul Immunol Inflamm. 2010 Oct;18(5):352-61. doi: 10.3109/09273948.2010.498657.

Results Reference

result

PubMed Identifier

11879137

Citation

Kunert KS, Tisdale AS, Gipson IK. Goblet cell numbers and epithelial proliferation in the conjunctiva of patients with dry eye syndrome treated with cyclosporine. Arch Ophthalmol. 2002 Mar;120(3):330-7. doi: 10.1001/archopht.120.3.330. Erratum In: Arch Ophthalmol 2002 Aug;120(8):1099.

Results Reference

result

PubMed Identifier

18848318

Citation

Kim EC, Choi JS, Joo CK. A comparison of vitamin a and cyclosporine a 0.05% eye drops for treatment of dry eye syndrome. Am J Ophthalmol. 2009 Feb;147(2):206-213.e3. doi: 10.1016/j.ajo.2008.08.015. Epub 2008 Oct 9.

Results Reference

result

PubMed Identifier

9894935

Citation

Barr JT, Schechtman KB, Fink BA, Pierce GE, Pensyl CD, Zadnik K, Gordon MO. Corneal scarring in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study: baseline prevalence and repeatability of detection. Cornea. 1999 Jan;18(1):34-46.

Results Reference

result

PubMed Identifier

17508121

Citation

Research in dry eye: report of the Research Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):179-93. doi: 10.1016/s1542-0124(12)70086-1.

Results Reference

result

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

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