Keratoconjunctivitis SiccaPhase 4NCT02139033
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome
A Phase 4 study testing Retaine™ in people with Keratoconjunctivitis Sicca, run by Ocusoft, Inc. at 1 site in United States.
Trial summary
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- Retaine™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2014
- 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 or desire to use eye drops;
Who cannot join
- Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- Have used Restasis® within 30 days of Visit 1;
- Be a woman who is pregnant, nursing or planning a pregnancy;
- Be unwilling to submit a urine pregnancy test if of childbearing potential;
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- 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;
- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center Evaluation of Retaine™ Ophthalmic Emulsion in the Management of Tear Film Stability and Ocular Surface Staining in Patients Diagnosed With Dry Eye
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- Retaine™
- Keywords
- Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retaine™Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Retain 1-2 drops, bilaterally, BID Receives: Drug: Retaine™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Film Break-Up Time
Measured: Day 15
Ocular surface damage as measured by fluorescein staining
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocusoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139033
- Sponsor's protocol ID
- 13-110-0008
- Status last verified
- Jun 2014
- First submitted
- 6 May 2014
- Last updated
- 11 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Evaluation of Retaine™ Ophthalmic Emulsion in the Management of Tear Film Stability and Ocular Surface Staining in Patients Diagnosed With Dry Eye
- ClinicalTrials.gov ID
- NCT02139033
- Acronym / sponsor ID
- 13-110-0008
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ocusoft, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 May 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.
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Retaine™Retain 1-2 drops, bilaterally, BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age;
- Provide written informed consent;
- Have a reported history of dry eye;
- Have a history of use or desire to use eye drops;
Key exclusion criteria (9 listed)
- Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- Have used Restasis® within 30 days of Visit 1;
- 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 |
|---|---|---|
| Retaine™ | Drug | Arm 1 |
Primary outcome
Tear Film Break-Up Time
Time frame: Day 15
Ocular surface damage as measured by fluorescein staining
Time frame: Day 15
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 11 Jun 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 4 study testing Retaine™ in people with Keratoconjunctivitis Sicca, run by Ocusoft, Inc. 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 4 inclusion and 9 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 11 Jun 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 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?
Tear Film Break-Up Time (time frame: Day 15). The study lists 2 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 11 Jun 2014.