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

NCT04541888 | Completed Phase 3

• 1 other identifier: ZKY-CSA-202001
• Study Type: interventional
• Target: 644
• 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 dry eye disease .

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Proportion of patients whose corneal fluorescein staining score (ICSS) decreased by ≥1 point from baseline at visit 5 (study eye)

  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 Outcomes (6)

• EDS score at the NO.3, NO.4 and NO.5 visit was compared with the baseline EDS score (binocular)

  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)

  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)

  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)

  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)

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; Drug: Hypromellose Eye Drop

Control group

PLACEBO COMPARATOR

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; Drug: Hypromellose Eye Drop

Interventions

CsA Ophthalmic Gel DRUG

The CsA eye gel of 0.3 g: 0.15 mg

Also known as: CsA gel

Experimental Group

Placebo DRUG

Placebo

Control group

Hypromellose Eye Drop DRUG

Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop

Also known as: zhenshishuang

Control group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）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
• EDS score is more than 40 points;
• BUT is less than 10 s;
• Schirmer test result is less than 10mm/5 min;
• 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.

You may not qualify if:

• Severe dry eye patients requiring surgical treatment
• 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
• Patients receiving permanent lacrimal insertion or patients receiving temporary lacrimal insertion within 6 months prior to screening;
• Operation-induced dry eye
• Glaucoma patients;
• Unwilling to avoid wearing contact lenses;
• Systemic inflammation or active eye infection and blepharitis;
• Patients with multiple episodes of viral keratitis
• Patients with ocular cicatricial pemphigoid, obvious conjunctival scar, ocular chemical burn and neurotrophic keratoconjunctivitis
• 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;
• Perimenopausal women are taking hormone replacement therapy
• Patients who cannot stop using other eye drops and other ophthalmic preparations during the study period;
• Patients with severe cardiopulmonary diseases, uncontrolled hypertension and diabetes, etc. that affect the collection or compliance of study parameters;
• ALT and AST ≥ 2 times of the normal upper limit, and serum creatinine ≥ 1.5 times of the normal upper limit
• With a history of central nervous system disease or epilepsy, and/or a mental state that does not cooperate

Sponsors & Collaborators

• Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.: lead

Study Sites (1)

Ophthalmological Center of Zhongshan University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (9)

• 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

• Strong B, Farley W, Stern ME, Pflugfelder SC. Topical cyclosporine inhibits conjunctival epithelial apoptosis in experimental murine keratoconjunctivitis sicca. Cornea. 2005 Jan;24(1):80-5. doi: 10.1097/01.ico.0000133994.22392.47.

  PMID: 15604871 RESULT

• Perry HD, Doshi-Carnevale S, Donnenfeld ED, Solomon R, Biser SA, Bloom AH. Efficacy of commercially available topical cyclosporine A 0.05% in the treatment of meibomian gland dysfunction. Cornea. 2006 Feb;25(2):171-5. doi: 10.1097/01.ico.0000176611.88579.0a.

  PMID: 16371776 RESULT

• Leonardi A, Messmer EM, Labetoulle M, Amrane M, Garrigue JS, Ismail D, Sainz-de-la-Maza M, Figueiredo FC, Baudouin C. Efficacy and safety of 0.1% ciclosporin A cationic emulsion in dry eye disease: a pooled analysis of two double-masked, randomised, vehicle-controlled phase III clinical studies. Br J Ophthalmol. 2019 Jan;103(1):125-131. doi: 10.1136/bjophthalmol-2017-311801. Epub 2018 Mar 15.

  PMID: 29545413 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

• Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.

  PMID: 28079022 RESULT

• Tauber J, Karpecki P, Latkany R, Luchs J, Martel J, Sall K, Raychaudhuri A, Smith V, Semba CP; OPUS-2 Investigators. Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study. Ophthalmology. 2015 Dec;122(12):2423-31. doi: 10.1016/j.ophtha.2015.08.001. Epub 2015 Sep 11.

  PMID: 26365210 RESULT

• Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.

  PMID: 14508260 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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: November 5, 2020
• Primary Completion: August 16, 2021
• Study Completion: October 14, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)