Dry Eye SyndromesPhase 3HL_TSPR_302NCT02229955
Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease
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.
Trial summary
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. 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
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Jul 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 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 One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)
- Non-anesthetic Schirmer test value ≤ 10mm/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)
- Tear break-up time is 10 seconds or less
- 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.)
Who cannot join
- Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.
- 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
- current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- The use in clinical trials of drug hypersensitivity reactions in patients
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
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
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
- Conditions
- Dry Eye Syndromes
- Being tested
- Cyclosporine ophthalmic solution
- Keywords
- Dry Eye Syndromes
- 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 group | Role | What they receive |
|---|---|---|
| T-sporin eye drop | Experimental | Cyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes Receives: Drug: Cyclosporine ophthalmic solution |
| Restasis eye drop | Active comparator | Cyclosporine 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.
Corneal staining test
Measured: 12 weeks
Secondary outcomes (5)
Corneal staining test
Measured: 4, 8 weeks
Ocular surface disease index (OSDI)
Measured: 4, 8, 12 weeks
Tear break up time (TBUT)
Measured: 4, 8, 12 weeks
Non-anesthetic Schirmer test
Measured: 4, 8, 12 weeks
Conjunctival staining
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.
- First posted3 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229955
- Sponsor's protocol ID
- HL_TSPR_302
- Acronym
- HL_TSPR_302
- Status last verified
- Aug 2014
- First submitted
- 29 Aug 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02229955
- Acronym / sponsor ID
- HL_TSPR_302 / HL_TSPR_302
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Sep 2014 (estimated)
- 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-sporin eye drop | Experimental | Drug: Cyclosporine ophthalmic solutionCyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes |
| Restasis eye drop | Active comparator | Drug: Cyclosporine ophthalmic solutionCyclosporine 0.05% : 1 drop twice a day for 12 weeks to both eyes |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- [Patients with moderate-to-severe ocular dry eye]
- The One eye of corneal fluorescein staining score of 2 or higher (Oxford grading)
- Non-anesthetic Schirmer test value ≤ 10mm/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)
- Tear break-up time is 10 seconds or less
- Screening both eyes, the corrected visual acuity is 0.2 or more
Key exclusion criteria (7 listed)
- Screening visits in the previous 3 months (12 weeks) who participated in the clinical trials of cyclosporine eye drops, or if you used a cyclosporin ophthalmic solutions.
- The patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
- current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- The use in clinical trials of drug hypersensitivity reactions in patients
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 |
|---|---|---|
| Cyclosporine ophthalmic solutionAlso: Restasis Eye Drops, Tisporin Eye Drops1 drop twice/day for 12 weeks to both eyes | Drug | Restasis eye drop, T-sporin eye drop |
Primary outcome
Corneal staining test
Time frame: 12 weeks
5 secondary outcomes
Corneal staining test
Time frame: 4, 8 weeks
Ocular surface disease index (OSDI)
Time frame: 4, 8, 12 weeks
Tear break up time (TBUT)
Time frame: 4, 8, 12 weeks
Non-anesthetic Schirmer test
Time frame: 4, 8, 12 weeks
Conjunctival staining
Time frame: 4, 8, 12 weeks
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 3 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 6 inclusion and 7 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 Sep 2014. 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?
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 Sep 2014.