Dry Eye SyndromesPhase 4NCT03183089
Comparative Study of Rohto Dry-Aid® and Systane® Ultra in Patients With Dry Eye
A Phase 4 study testing Rohto Dry-Aid® and Systane® Ultra in people with Dry Eye Syndromes and Dry Eye, run by The Mentholatum Company at 1 site in United States.
Trial summary
The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Dry Eye
- What is being tested?
- Rohto Dry-Aid® and Systane® Ultra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2015to 4 Jan 2016
- Phase
- Phase 4
- 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
- Be at least 18 years of age
- Provide written informed consent
- Have a reported history of dry eye
- Have a history of use of eye drops for dry eye symptoms
- Ocular discomfort
- Conjunctival redness
- Tear film break up time
- Corneal and Conjunctival Staining
Who cannot join
- Have any clinically significant slit lamp findings at entry visit
- Be diagnosed with an ongoing ocular infection
- Have any planned ocular and/or lid surgeries over the study period
- Have an uncontrolled systemic disease
- Be a woman who is pregnant, nursing or planning a pregnancy
- Be a woman of childbearing potential who is not using an acceptable means of birth control
- Have a known allergy and/or sensitivity to the test article or its components
- Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Randomized, Single-Center, Comparative Study of Rohto Dry-Aid® and Systane® Ultra in the Management of Tear Film Stability and Visual Function in Patients With Dry Eye
The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.
- Conditions
- Dry Eye Syndromes, Dry Eye
- Being tested
- Rohto Dry-Aid®, Systane® Ultra
- 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.
Rohto Dry-Aid®Drug
Systane® UltraDrug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: Rohto Dry-Aid® |
| Active Comparator | Active comparator | Not described Receives: Drug: Systane® Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry Eye Staining
Dry eye syndrome corneal and conjunctival staining assessment
Measured: 28 days
Dry Eye Symptom Questionnaire
Symptom assessment questionnaire
Measured: 28 days
Tear Film Break Up Time
Tear Film Break Up Time after instillation of fluorescein dye
Measured: 28 days
Visual Function Assessment
Reading Test
Measured: 28 days
Secondary outcomes (4)
Drop Comfort Assessment
The comfort of the eye drop will be performed to assess changes from baseline
Measured: Day 1
Visual Acuity
Visual Acuity will be measured using the EDTRS chart to assess changes from baseline
Measured: 28 Days
Slit-Lamp Biomicroscopy
Slit lamp biomicroscopy exams will be performed to assess any changes from baseline
Measured: 28 Days
Adverse Event
Adverse Event queries
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start3 Dec 2015
- Primary completion4 Jan 2016
- Study completion4 Jan 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mentholatum Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail L Torkildsen, M.D., Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183089
- Sponsor's protocol ID
- 15-110-0011
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Center, Comparative Study of Rohto Dry-Aid® and Systane® Ultra in the Management of Tear Film Stability and Visual Function in Patients With Dry Eye
- ClinicalTrials.gov ID
- NCT03183089
- Acronym / sponsor ID
- 15-110-0011
- Conditions
- Dry Eye Syndromes, Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Mentholatum CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 4 Jan 2016 (actual)
- Study completion
- 4 Jan 2016 (actual)
- First posted
- 9 Jun 2017 (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.
The objective of this study is to evaluate the efficacy of Rohto Dry-Aid® in comparison to Systane® Ultra on visual function and tear film stability in patients diagnosed with Dry Eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Rohto Dry-Aid® |
| Active Comparator | Active comparator | Drug: Systane® Ultra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be at least 18 years of age
- Provide written informed consent
- Have a reported history of dry eye
- Have a history of use of eye drops for dry eye symptoms
- Ocular discomfort
Key exclusion criteria (8 listed)
- Have any clinically significant slit lamp findings at entry visit
- Be diagnosed with an ongoing ocular infection
- Have any planned ocular and/or lid surgeries over the study period
- Have an uncontrolled systemic disease
- Be a woman who is pregnant, nursing or planning a pregnancy
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 |
|---|---|---|
| Rohto Dry-Aid® | Drug | Active |
| Systane® Ultra | Drug | Active Comparator |
Primary outcome
Dry Eye Staining
Time frame: 28 days
Dry eye syndrome corneal and conjunctival staining assessment
Dry Eye Symptom Questionnaire
Time frame: 28 days
Symptom assessment questionnaire
Tear Film Break Up Time
Time frame: 28 days
Tear Film Break Up Time after instillation of fluorescein dye
Visual Function Assessment
Time frame: 28 days
Reading Test
4 secondary outcomes
Drop Comfort Assessment
Time frame: Day 1
Visual Acuity
Time frame: 28 Days
Slit-Lamp Biomicroscopy
Time frame: 28 Days
Adverse Event
Time frame: 28 Days
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 9 Jun 2017.
- 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.
Gail L Torkildsen, M.D. principal investigator
Andover Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rohto Dry-Aid® and Systane® Ultra in people with Dry Eye Syndromes and Dry Eye, run by The Mentholatum Company at 1 site in United States.
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 8 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 9 Jun 2017. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Dry Eye Staining (time frame: 28 days). The study lists 4 primary outcomes in all. 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 9 Jun 2017.