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Dry Eye SyndromesPhase 3NCT02461719

Efficacy and Safety Study of TJCS for Treatment of Moderate to Severe Dry Eye Syndromes

A Phase 3 study testing CYPORIN N EYE DROPS 0.05%(TJCS eye drop) and Restasis in people with Dry Eye Syndromes, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.

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 clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Dry Eye Syndromes
What is being tested?
CYPORIN N EYE DROPS 0.05%(TJCS eye drop) and Restasis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteSouth Korea
Study dates
Jan 2014to Oct 2014
Phase
Phase 3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age 20 or over
  • Patients with moderate to severe dry eye
  • Screening both eyes, the corrected visual acuity is 0.2 or more

Who cannot join

  • Screening visits within 4 weeks who treated with systemic cyclosporine or topical cyclosporine ophthalmic solutions.
  • Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
  • Intraocular pressure(IOP)> 25 mmHg
  • Patient using or to use punctual plug within 1 months.
  • Patients with contact lens.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Multicenter, Randomized, Double-blind phⅢ Study of TJCS Eye Drops Group and Restasis Eye Drops Group for 12 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease.

The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.

Being tested
CYPORIN N EYE DROPS 0.05%(TJCS eye drop), Restasis
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.

  • CYPORIN N EYE DROPS 0.05%(TJCS eye drop)Drug

    Also called Cyclosporine Eye Drops(CYPORIN N)

    1 drop twice/day for 12 weeks to both eyes.

  • RestasisDrug

    Also called Cyclosporine Eye Drops (Restasis)

    1 drop twice/day for 12 weeks to both eyes. Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using.

Study groups in NCT02461719
Study groupRoleWhat they receive
CYPORIN N EYE DROPS 0.05%(TJCS eye drop)ExperimentalCYPORIN N EYE DROPS 0.05%(TJCS eye drop) 1 drop twice/day for 12 weeks to both eyes
Receives: Drug: CYPORIN N EYE DROPS 0.05%(TJCS eye drop)
Restasis eye dropActive comparatorRestasis eye drop(Cyclosporine ophthalmic solution 0.05%) 1 drop twice/day for 12 weeks to both eyes
Receives: Drug: Restasis

What is being measured

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

  1. Corneal staining test

    Measured: 12 weeks

Secondary outcomes (7)

  1. Corneal staining test

    Measured: 4, 8 weeks

  2. Conjunctival staining

    Measured: 4, 8, 12 weeks

  3. Corneal and Conjunctival staining sum Score

    Measured: 4, 8, 12 weeks

  4. Ocular surface disease index (OSDI)

    Measured: 4, 8, 12 weeks

  5. Tear break up time (TBUT)

    Measured: 4, 8, 12 weeks

  6. Non-anesthetic Schirmer test

    Measured: 4, 8, 12 weeks

  7. Frequency of concurrent drug use

    Measured: 4, 8, 12 weeks

Timeline

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

  1. First posted3 Jun 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionSep 2014
  4. Study completionOct 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02461719
Sponsor's protocol ID
TJCS_P3
Status last verified
May 2015
First submitted
1 Jun 2015
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CYPORIN N EYE DROPS 0.05%(TJCS eye drop) and Restasis in people with Dry Eye Syndromes, run by Taejoon Pharmaceutical Co., Ltd. at 1 site in South Korea.

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 3 inclusion and 5 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 3 Jun 2015. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Corneal staining test (time frame: 12 weeks). 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 NCT02461719.

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 3 Jun 2015.

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