Dry EyePhase 2NCT02116244
Civamide Nasal Solution for the Treatment of Dry Eye
A Phase 2 study testing Civamide Nasal Spray in people with Dry Eye, run by Winston Laboratories at 3 sites in United States.
Trial summary
Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye, tear film, and related ocular tissues. Millions of people suffer from one form of the disease or another and its prevalence increases with age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Civamide Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to Sep 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
- Patients must be aged 18 years or older.
- Patients must have documented moderate to severe evaporative Dry Eye Syndrome for at least 6 months.
- Patients must have a Schirmer (with anesthesia) of ≤ 8 per 5 minutes in at least one eye at Screening and Baseline (Day 1).
- Patients must have a calculated overall score on the OSDI of >0.1 with no more than three responses of not applicable (N/A) at Screening and Baseline (Day 1).
- Patients must have normal lid position and closure.
- Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative urine pregnancy test is required within 14 days of Day 1.
- Informed consent must be provided.
Who cannot join
- Patients with severe inflammatory Dry Eye Syndrome.
- Patients with Dry Eye Syndrome secondary to Sjögren's Syndrome.
- Patients with Schirmer (with anesthesia) of >8 per 5 minutes in both eyes.
- Patients who are allergic to Civamide or any similar products, or excipients of Civamide Nasal Solution 0.01%.
- Patients with history of previous ocular surgery or trauma.
- Patients who require concurrent ocular medication for any eye disorder.
- Patients who have used Restasis®, serum tears, or oral omega 3 supplements during the last 30 days or oral cyclosporine during the last 90 days.
- Patients who are receiving or have received within 30 days any experimental systemic medication.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Wohl Eye Center
Bloomingdale, Illinois, 60108
NorthShore University HealthSystem
Glenview, Illinois, 60026
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, 60169
About this study
Official title: A Phase II, Open-label, Tolerability and Efficacy Study of Civamide Nasal Solution, 0.01%, in Patients With Dry Eye Syndrome
Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye, tear film, and related ocular tissues. Millions of people suffer from one form of the disease or another and its prevalence increases with age. Dry Eye Syndrome sufferers experience a broad range of symptoms including discomfort, irritation, burning, itching, redness, pain, gritty feeling, foreign body sensation, blurred vision and ocular fatigue. Civamide is a TRPV-1 receptor modulator that causes the initial stimulation of neuropeptide release and subsequent desensitization to further stimulation of the trigeminovascular system. This provides a pharmacological rational for intranasal route of administration for disorders mediated by the trigeminal nerve or involving the cranial nerve. In nine clinical studies of Civamide Nasal Solution, over 50% of the nearly 300 patients who received Civamide via intranasal administration experienced lacrimation (tearing). This led to the hypothesis that Civamide Nasal Solution might be an appropriate treatment for Dry Eye Syndrome.
- Conditions
- Dry Eye
- Being tested
- Civamide Nasal Spray
- Keywords
- Dry Eye, Civamide, Zucapsaicin, Neuropeptides, TRPV-1
- 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.
Civamide Nasal SprayDrug
| Study group | Role | What they receive |
|---|---|---|
| Civamide Nasal Spray | Experimental | Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily for 12 weeks Receives: Drug: Civamide Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer Test
Change in Schirmer Test from the Baseline Period to the last week (Week 12) of the Treatment Period.
Measured: 12 Weeks
Secondary outcomes (1)
Schirmer Test
Change in Schirmer Test from the Baseline Period to the Score of each of weeks 1 and 6
Measured: Week 1 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott B Phillips, MD, Study director, Winston Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116244
- Sponsor's protocol ID
- WL-1001-08-02
- Status last verified
- Feb 2017
- First submitted
- 14 Apr 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Tolerability and Efficacy Study of Civamide Nasal Solution, 0.01%, in Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02116244
- Acronym / sponsor ID
- WL-1001-08-02
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Civamide, Zucapsaicin, Neuropeptides, TRPV-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Winston LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Apr 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.
Keratoconjunctivitis sicca (KCS) or Dry Eye Syndrome is a disease of the surface of the eye, tear film, and related ocular tissues. Millions of people suffer from one form of the disease or another and its prevalence increases with age. Dry Eye Syndrome sufferers experience a broad range of symptoms including discomfort, irritation, burning, itching, redness, pain, gritty feeling, foreign body sensation, blurred vision and ocular fatigue. Civamide is a TRPV-1 receptor modulator that causes the initial stimulation of neuropeptide release and subsequent desensitization to further stimulation of the trigeminovascular system. This provides a pharmacological rational for intranasal route of administration for disorders mediated by the trigeminal nerve or involving the cranial nerve. In nine clinical studies of Civamide Nasal Solution, over 50% of the nearly 300 patients who received Civamide via intranasal administration experienced lacrimation (tearing). This led to the hypothesis that Civamide Nasal Solution might be an appropriate treatment for 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 |
|---|---|---|
| Civamide Nasal Spray | Experimental | Drug: Civamide Nasal SprayCivamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be aged 18 years or older.
- Patients must have documented moderate to severe evaporative Dry Eye Syndrome for at least 6 months.
- Patients must have a Schirmer (with anesthesia) of ≤ 8 per 5 minutes in at least one eye at Screening and Baseline (Day 1).
- Patients must have a calculated overall score on the OSDI of >0.1 with no more than three responses of not applicable (N/A) at Screening and Baseline (Day 1).
- Patients must have normal lid position and closure.
Key exclusion criteria (8 listed)
- Patients with severe inflammatory Dry Eye Syndrome.
- Patients with Dry Eye Syndrome secondary to Sjögren's Syndrome.
- Patients with Schirmer (with anesthesia) of >8 per 5 minutes in both eyes.
- Patients who are allergic to Civamide or any similar products, or excipients of Civamide Nasal Solution 0.01%.
- Patients with history of previous ocular surgery or trauma.
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 |
|---|---|---|
| Civamide Nasal Spray | Drug | Civamide Nasal Spray |
Primary outcome
Schirmer Test
Time frame: 12 Weeks
Change in Schirmer Test from the Baseline Period to the last week (Week 12) of the Treatment Period.
1 secondary outcome
Schirmer Test
Time frame: Week 1 and 6
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 10 Feb 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.
Scott B Phillips, MD study director
Winston Laboratories
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Civamide Nasal Spray in people with Dry Eye, run by Winston Laboratories at 3 sites 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 7 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Schirmer 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 10 Feb 2017.