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

NCT03676335 | Completed Phase 2

• 1 other identifier: ZK-CSA-201704
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

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

  0-100 points VAS score was evaluated

  84 days after admission

Secondary Outcomes (5)

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

  14 days after admission ，42days 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)

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

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

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

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

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

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

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

Study Arms (4)

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

EXPERIMENTAL

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; Drug: Hypromellose Eye Drops

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

EXPERIMENTAL

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; Drug: Hypromellose Eye Drops

0.3 g: 0.3 mg &Hypromellose Eye Drops

EXPERIMENTAL

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; Drug: Hypromellose Eye Drops

0.4 ml: 0.2 mg &Hypromellose Eye Drops

ACTIVE COMPARATOR

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; Drug: Hypromellose Eye Drops

Interventions

CsA eye gel DRUG

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

Also known as: CsA gel

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

CsA for eye emulsion DRUG

The CsA for eye emulsion of 0.4 ml: 0.2 mg

Also known as: CsA emulsion

0.4 ml: 0.2 mg &Hypromellose Eye Drops

Hypromellose Eye Drops DRUG

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

Also known as: zhenshishuang

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Ophthalmological Center of Zhongshan University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

• 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.

  PMID: 20735287 RESULT

• 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.

  PMID: 11879137 RESULT

• 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.

  PMID: 18848318 RESULT

• 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.

  PMID: 9894935 RESULT

• 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.

  PMID: 17508121 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• shiyou zhou, PHD

  Ophthalmological Center of Zhongshan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 18, 2018
• Study Start: May 9, 2018
• Primary Completion: June 30, 2019
• Study Completion: December 12, 2019
• Last Updated: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)