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Dry Eye SyndromesPhase 3CyclosporineNCT01768312

Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group

A Phase 3 study testing Cyclosporine ophthalmic solution in people with Dry Eye Syndromes, run by Hanlim Pharm. 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

A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Dry Eye Syndromes
What is being tested?
Cyclosporine ophthalmic solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteSouth Korea
Study dates
23 Aug 2012to 31 Jul 2013
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • [Patients with moderate-to-severe ocular dry eye]
  • The sum of corneal fluorescein staining score of 5 or higher (NEI Scale)
  • Non-anesthetic Schirmer test value ≤ 5mm/5min patients at least one eye score (Non-anesthetic Schirmer test value = 0/5min, nasal stimulation in the same eye, Schirmer test value ≥ 3mm/5min)
  • Screening both eyes, the corrected visual acuity is 0.2 or more
  • Despite conventional treatment, the symptoms of dry eye signs (Artificial tear eye drops, sympathetic nervous system stimulant agent, parasympathetic nerve stimulant, etc.)
  • Negative urine pregnancy test at the screening when women of childbearing age
  • Medically reliable method of contraception in the case of all women of childbearing age or menopause (1 year after the last menstrual period women) Sterilization (eg, bilateral oophorectomy, hysterectomy) women of childbearing age have not been effective contraception only if you participate in a clinical trial may have been determined to be pregnant by examining whether the voice, maintained during the entire clinical trial period shall that.
  • Written consent voluntarily to participate in this clinical trial

Who cannot join

  • 1) Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporine ophthalmic solutions.
  • 2) The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
  • Abnormal eyelid function : Disoders of the eyelids or eyelashes
  • Ocular allergies or currently under the treatment of allergic diseases of the eye (topical ocular mast cell stabilizer, antihistamine use, etc.)
  • Cicatricial keratoconjunctivitis caused by herpetic keratopathy, conjunctival scarring (alkali damage, Steven-Johnson syndrome, cicatricial pemphigoid), pterygium, pinguecula, lack of congenital lacrimal, neurogenic keratitis, keratoconus, corneal transplantation 3) current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status 4) The use in clinical trials of drug hypersensitivity reactions in patients 5) patients with contact lens 6) If you use or plan to use punctual plug within 4 weeks 7) Lacrimal punctual occlusion surgery patients 8) Ocular surgery within 3 months (12 weeks) 9) Pregnant women, lactating, or planning to become pregnant 10) The end of the lacrimal gland disease (Nasal stimulation Schirmer test value <3mm/5min) 11) History of malignancy 12) If you are receiving systemic steroids or immunosuppressive treatment 15) In patients with severe renal failure (serum creatinine more than 2.0 times the upper limit of normal) 16) In patients with severe liver dysfunction (ALT or AST of more than 2.0 times the upper limit of normal) 17) Alcohol or drug abuse 18) Pregnant women, lactating women 19) Participating in a Clinical Trial patients who have participated in other clinical trials within three months 20) Patients judged coexisting disease that could interfere with the completion of the treatment or safety of this clinical trial. Patients that other researchers are determined inadequately

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The catholic university of Korea seoul st. Mary's hospital

    Seoul, Seocho-Ku, 137-701

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease

A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease

Read the detailed description

The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) 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.

  • Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test
Being tested
Cyclosporine ophthalmic solution
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.

  • Cyclosporine ophthalmic solutionDrug

    Also called Restasis Eye Drops, Tisporin Eye Drops

    1 drop twice/day for 12 weeks to both eyes

Study groups in NCT01768312
Study groupRoleWhat they receive
Restasis eye dropActive comparatorCyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
Receives: Drug: Cyclosporine ophthalmic solution
T-sporin eye dropExperimentalCyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes
Receives: Drug: Cyclosporine ophthalmic solution

What is being measured

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

  1. Corneal staining test

    The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system

    Measured: Administered 12 weeks after

Secondary outcomes (5)

  1. Tear break up time (TBUT)

    After blinking blue fluorescein staining of the cobalt blue light source using a yellow filter, it was observed from the blinking point that there was a black spot, a streak pattern or a fluorine defect in the fluorescein-tear layer Was measured in seconds. The measurement results were repeated three times and average values were used.

    Measured: Administered 4, 8, 12 weeks after

  2. Corneal staining test

    Corneal staining was performed at each visit. The degree of staining of the cornea after blue fluorescein staining under the slit lamp illumination of a cobalt blue light source using a yellow filter was evaluated on a 6 point scale according to the oxford grading system

    Measured: Administered 4, 8 weeks after

  3. Ocular surface disease index (OSDI)

    The ocular surface disease index was assessed for ocular surface disease, including visual function (five items), eye symptoms (four items), and environmental factors (three items) , 0 point for no symptoms, 1 point for occasional symptoms, 2 points for symptoms of half a day, 3 points for most symptoms, and 4 points for symptoms during the whole day.

    Measured: Administered 4, 8, 12 weeks after

  4. Non-anesthetic Schirmer test

    After the eyes were examined, the eyes were wiped and the Schirmer test paper was inserted into the right eye at 1/3 of the lower eyelid without eye anesthesia and inserted into the left eye. After 5 minutes with the eyes closed, the Schirmer test paper was removed from the right side in the order of insertion and the left side removed. The wet length was measured in millimeters and the length of the midpoint was measured when the wet border was oblique.

    Measured: Administered 4, 8, 12 weeks after

  5. Conjunctival staining

    After lysamine green staining under slit lamps, the conjunctiva was divided into the nasal side and the lateral side, and the degree of nasal conjunctiva and bilateral conjunctival staining was evaluated on a 6-point scale according to the oxford grading system

    Measured: Administered 4, 8, 12 weeks after

Timeline

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

  1. First posted15 Jan 2013 (estimated)
  2. Study start23 Aug 2012
  3. Primary completion31 Jul 2013
  4. Study completion31 Jul 2013

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
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01768312
Sponsor's protocol ID
HL_TSPR_301
Acronym
Cyclosporine
Status last verified
Aug 2018
First submitted
10 Dec 2012
Last updated
29 Aug 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclosporine ophthalmic solution in people with Dry Eye Syndromes, run by Hanlim Pharm. 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 8 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 29 Aug 2018. 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: Administered 12 weeks after). 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 NCT01768312.

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 29 Aug 2018.

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