Dry EyePhase 2NCT03676335

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

A Phase 2 study testing CsA eye gel, CsA for eye emulsion and Hypromellose Eye Drops in people with Dry Eye, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye
What is being tested?: CsA eye gel, CsA for eye emulsion and Hypromellose Eye Drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteChina
Study dates: 9 May 2018to 12 Dec 2019
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Show all 11Show fewer

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.

Who cannot join

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;

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Ophthalmological Center of Zhongshan University
Guangzhou, Guangdong, 510060

Other trials in China

About this study

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)

Read the 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.

Conditions: Dry Eye
Being tested: CsA eye gel, CsA for eye emulsion, Hypromellose Eye Drops
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CsA eye gelDrug
Also called CsA gel
The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
CsA for eye emulsionDrug
Also called CsA emulsion
The CsA for eye emulsion of 0.4 ml: 0.2 mg
Hypromellose Eye DropsDrug
Also called zhenshishuang
Hypromellose Eye Drops of 15ml：75mg, 3 times daily, 1-2 drop

Study groups in NCT03676335
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: CsA for eye emulsion; Drug: Hypromellose Eye Drops

What is being measured

The primary outcome is the main question the study is designed to answer.

The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular)
0-100 points VAS score was evaluated
Measured: 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)
0-100 points VAS score was evaluated
Measured: 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)
0-100 points VAS score was evaluated
Measured: 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
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）
Measured: 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
time
Measured: 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
Basal tear secretion
Measured: 14 days after admission ，42 days after admission ，84 days after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201812 Dec 2019

First posted18 Sep 2018
Study start9 May 2018
Primary completion30 Jun 2019
Study completion12 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03676335
Sponsor's protocol ID: ZK-CSA-201704
Status last verified: May 2020
First submitted: 30 Aug 2018
Last updated: 8 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 20735287
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.
PubMed 11879137
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.
PubMed 18848318
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.
PubMed 9894935
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.
PubMed 17508121

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03676335
Acronym / sponsor ID: ZK-CSA-201704
Conditions: Dry Eye
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.Industry (pharma, biotech, devices)
Study start: 9 May 2018 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 12 Dec 2019 (actual)
First posted: 18 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
0.3 g: 0.15 mg（1)&Hypromellose Eye Drops	Experimental	Drug: CsA eye gel, Drug: Hypromellose Eye DropsSixty 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.
0.3 g: 0.15mg（2)&Hypromellose Eye Drops	Experimental	Drug: CsA eye gel, Drug: Hypromellose Eye DropsSixty 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.
0.3 g: 0.3 mg &Hypromellose Eye Drops	Experimental	Drug: CsA eye gel, Drug: Hypromellose Eye DropsSixty 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.
0.4 ml: 0.2 mg &Hypromellose Eye Drops	Active comparator	Drug: CsA for eye emulsion, Drug: Hypromellose Eye DropsSixty 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;
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;

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CsA eye gelAlso: CsA gelThe CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg	Drug	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 emulsionAlso: CsA emulsionThe CsA for eye emulsion of 0.4 ml: 0.2 mg	Drug	0.4 ml: 0.2 mg &Hypromellose Eye Drops
Hypromellose Eye DropsAlso: zhenshishuangHypromellose Eye Drops of 15ml：75mg, 3 times daily, 1-2 drop	Drug	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

Primary outcome

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

5 secondary outcomes

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
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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
Results publication: PubMed 20735287Utine 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 publication: PubMed 11879137Kunert 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.
Results publication: PubMed 18848318Kim 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 publication: PubMed 9894935Barr 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 publication: PubMed 17508121Research 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

shiyou zhou, PHD study director

Ophthalmological Center of Zhongshan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CsA eye gel, CsA for eye emulsion and Hypromellose Eye Drops in people with Dry Eye, run by Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular) (time frame: 84 days after admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03676335, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.