Dry Eye SyndromePhase 2NCT02326090
Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
A Phase 2 study testing cis-UCA ophthalmic solution 1.0% and cis-UCA ophthalmic solution 2.5% in people with Dry Eye Syndrome, run by Herantis Pharma Plc. at 1 site in United States.
Trial summary
The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- cis-UCA ophthalmic solution 1.0% and cis-UCA ophthalmic solution 2.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Apr 2015
- Phase
- Phase 2
- 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 subject 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;
- Have any planned ocular and/or lid surgeries over the study period;
- Be a woman who is pregnant, nursing or planning a pregnancy;
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- Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential;
- Have a known allergy and/or sensitivity to the study drug 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;
- Be unable or unwilling to follow instructions, including participation in all study assessments and visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1.0% and 2.5% Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
- Conditions
- Dry Eye Syndrome
- Being tested
- cis-UCA ophthalmic solution 1.0%, cis-UCA ophthalmic solution 2.5%, Placebo 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.
cis-UCA ophthalmic solution 1.0%Drug
cis-UCA ophthalmic solution 2.5%Drug
Placebo ophthalmic solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| cis-UCA ophthalmic solution 1.0% | Active comparator | One drop in each eye Receives: Drug: cis-UCA ophthalmic solution 1.0% |
| cis-UCA ophthalmic solution 2.5% | Active comparator | One drop in each eye Receives: Drug: cis-UCA ophthalmic solution 2.5% |
| Placebo ophthalmic solution | Placebo comparator | One drop in each eye Receives: Drug: Placebo ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Fluorescein Staining
Measured: Day 29
Symptom Score
Measured: Day 22 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herantis Pharma Plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326090
- Sponsor's protocol ID
- CL12002 / 14-110-0005
- Status last verified
- Sep 2015
- First submitted
- 22 Dec 2014
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1.0% and 2.5% Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
- ClinicalTrials.gov ID
- NCT02326090
- Acronym / sponsor ID
- CL12002 / 14-110-0005
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Herantis Pharma Plc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Dec 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 objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cis-UCA ophthalmic solution 1.0% | Active comparator | Drug: cis-UCA ophthalmic solution 1.0%One drop in each eye |
| cis-UCA ophthalmic solution 2.5% | Active comparator | Drug: cis-UCA ophthalmic solution 2.5%One drop in each eye |
| Placebo ophthalmic solution | Placebo comparator | Drug: Placebo ophthalmic solutionOne drop in each eye |
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 subject reported history of dry eye;
- Have a history of use or desire to use eye drops.
Key exclusion criteria (11 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;
- Have any planned ocular and/or lid surgeries over the study period;
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 |
|---|---|---|
| cis-UCA ophthalmic solution 1.0% | Drug | cis-UCA ophthalmic solution 1.0% |
| cis-UCA ophthalmic solution 2.5% | Drug | cis-UCA ophthalmic solution 2.5% |
| Placebo ophthalmic solution | Drug | Placebo ophthalmic solution |
Primary outcome
Corneal Fluorescein Staining
Time frame: Day 29
Symptom Score
Time frame: Day 22 to 28
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 Sep 2015.
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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 2 study testing cis-UCA ophthalmic solution 1.0% and cis-UCA ophthalmic solution 2.5% in people with Dry Eye Syndrome, run by Herantis Pharma Plc. 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 11 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 Sep 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 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Fluorescein Staining (time frame: Day 29). 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 9 Sep 2015.