Dry EyePhase 1NCT01476332
Safety, Tolerability and Pharmacokinetics of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers (Phase I)
A Phase 1 study testing cis-urocanic acid 0,5% eye drops and cis-urocanic acid 2.5% eye drops in people with Dry Eye, run by Laurantis Pharma, Ltd. at 1 site in Finland.
Trial summary
The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- cis-urocanic acid 0,5% eye drops and cis-urocanic acid 2.5% eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2011to Mar 2012
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent obtained prior to any screening procedure
- Caucasian male or female subject
- Age 18-65 y
- Weight at least 45 kg
- Corrected visual acuity > 20/25 in both eyes
- Intraocular pressure < 21 mmHg, with a difference between eyes of < 4 mmHg
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- Ability to tolerate and self-administer vehicle eye drops
- Normal slit lamp examination and dilated fundoscopic examination
- Normal clinical laboratory profiles, defined as complete blood count, serum chemistry, and urinalysis values within the normal range
- Willingness to abstain from concomitant use of ocular or systemic medication (excluding oral contraceptives, ibuprofen, paracetamol, calcium preparations and vitamins) from 2 weeks prior to the start of study dosing until study completion
- Willingness to comply with study-related procedures
- Negative urine pregnancy test (premenopausal female subject) at screening and use of adequate contraceptive measures throughout the study and 30 days after the last study medication dose
- A premenopausal female subject should be either surgically sterile or using a reliable contraception method: intrauterine device; oral combination pill or hormonal contraception patch; or two of the following: intra-vaginal hormonal ring, oral contraceptive containing progestin only, spermicidal foam, condom, sterilization of male sexual partner (surgical vasectomy)
- Subject with no current heterosexual relationship may be included according to the judgment of the Investigator
- If menopause occurred 2 years ago at the minimum, no contraception is required for a female participant, nor pregnancy test
- Reliable contraception for a male subject is concordant with above listed methods for females, as applicable
Who cannot join
- History of ocular surgery, trauma, or chronic ocular disease
- Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day
- Any ocular abnormalities or ocular symptoms (defined as a non-zero score on assessment scales)
- Use of ocular agents (including all types of eye drops) within the past month prior to the first dosing day or anticipated use of ocular agents during the study period
- Use of systemic or inhaled nasal or pulmonary corticosteroids within the past month prior to the first dosing day
- Use of systemic antihistamines within one week prior to the first dosing day
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- History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis within 2 months prior to the first dosing day; history of herpes simplex keratitis at any time
- Current ocular allergy symptoms
- Loss, donation, or removal of 400 ml or more of blood within 2 months prior to the first dosing day
- Women who are pregnant or breastfeeding, or non-sterile or premenopausal women who refuse to use two proven methods of contraception during the study and for at least 30 days following the final dose of study drug
- Participation in another clinical drug or device study within 2 months prior to the first dosing day
- Current smoking
- Current or history of drug or alcohol abuse
- Known human immunodeficiency virus- or acquired immunodeficiency syndrome -related illness.
- Allergy to cis-UCA, or any constituents of the cis-UCA eye drops (cis-urocanic acid, aqua, sodium chloride, polyvinyl alcohol, sodium hydroxide, and/or hydrochloric acid) or placebo for cis-UCA eye drops (aqua, sodium chloride, polyvinyl alcohol, sodium hydroxide, and/or hydrochloric acid)
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, would affect the subject's ability to follow study-related procedures, or may interfere with the interpretation of study results and, in the Investigator's opinion, would make the subject inappropriate for entry into this study.
- Doubtful availability to complete the study
Trial locations and contacts
1 site in 1 country.
Finland1 site
Kuopio University Hospital, Department of Ophthalmology
Kuopio, 70200
About this study
Official title: A Single Dose (Part 1) and Multiple Dose (Part 2) Phase I, Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers
The purpose of this two-part study is to evaluate safety, tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.
Read the detailed description
This is a Phase I single-centre, double-blind, placebo-controlled, single and multiple dose study to evaluate safety, ocular tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in healthy volunteers for up to 15 days. After the single day dose (three times) on day 1 and the subsequent 7 (± 1) days wash-out period, a multidose phase with three times a day administration for 14 days will start
Primary objectives:
- Part 1: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on a randomized eye three times during a single day, assessed up to 7 (± 1) days following dosing in healthy volunteers
- Part 2: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on both eyes three times a day for 14 days, assessed up to 7 days following the last dosing in healthy volunteers
Secondary objectives:
- To evaluate single dose pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on a randomized eye in adult healthy volunteers
- To evaluate the pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on both eyes three times a day for 14 days in adult healthy volunteers
Healthy male or female volunteer, 18-65 years of age, with no history of significant eye disease or any current eye disease that would affect the pharmacokinetics of cis-UCA. Subjects without any treatment-emergent adverse events during Part 1 may continue to Part 2 of the study.
- Conditions
- Dry Eye
- Being tested
- cis-urocanic acid 0,5% eye drops, cis-urocanic acid 2.5% eye drops, Placebo for cis-UCA, eye drops
- Keywords
- eyes, cis-urocanic acid, safety, tolerability, pharmacokinetics
- 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-urocanic acid 0,5% eye dropsDrug
one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
cis-urocanic acid 2.5% eye dropsDrug
one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
Placebo for cis-UCA, eye dropsDrug
one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cis-UCA 0.5% eye drops | Experimental | Not described Receives: Drug: cis-urocanic acid 0,5% eye drops |
| Group 2: Cis-UCA 2.5% eye drops | Experimental | Not described Receives: Drug: cis-urocanic acid 2.5% eye drops |
| Group 3: Placebo for cis-UCA, eye drops | Placebo comparator | Not described Receives: Drug: Placebo for cis-UCA, eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
IER (Institute of Eye Research) grading scale evaluates bulbar conjunctival redness, lid redness and corneal staining and extent
Measured: 36 days
Secondary outcomes (5)
Ocular comfort rating
Measured: 36 days
Early Treatment Diabetic Retinopathy Study table, a visual acuity test
Measured: 36 days
Anterior chamber cells and flare using SUN Working Group Grading Schemes
Measured: 36 days
Ocular pressure
Measured: 36 days
Schirmer's test
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laurantis Pharma, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kuopio University Hospital
- Responsible party
- Sponsor
- Investigators
- Kai Kaarniranta, Professor, Principal investigator, Kuopio University Hospital, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476332
- Sponsor's protocol ID
- CL11001
- Other IDs
- 2011-004283-30
- Status last verified
- May 2012
- First submitted
- 10 Nov 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose (Part 1) and Multiple Dose (Part 2) Phase I, Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01476332
- Acronym / sponsor ID
- CL11001
- Conditions
- Dry Eye
- Keywords
- eyes, cis-urocanic acid, safety, tolerability, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Laurantis Pharma, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kuopio University Hospital
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Nov 2011 (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 two-part study is to evaluate safety, tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in comparison to placebo in adult healthy volunteers.
Detailed description
This is a Phase I single-centre, double-blind, placebo-controlled, single and multiple dose study to evaluate safety, ocular tolerability and pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops in healthy volunteers for up to 15 days. After the single day dose (three times) on day 1 and the subsequent 7 (± 1) days wash-out period, a multidose phase with three times a day administration for 14 days will start
Primary objectives:
- Part 1: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on a randomized eye three times during a single day, assessed up to 7 (± 1) days following dosing in healthy volunteers
- Part 2: To evaluate the safety and ocular tolerability of 0.5% and 2.5% cis-UCA eye drops and placebo for cis-UCA eye drops when administered on both eyes three times a day for 14 days, assessed up to 7 days following the last dosing in healthy volunteers
Secondary objectives:
- To evaluate single dose pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on a randomized eye in adult healthy volunteers
- To evaluate the pharmacokinetics of 0.5% and 2.5% cis-UCA eye drops when administered on both eyes three times a day for 14 days in adult healthy volunteers
Healthy male or female volunteer, 18-65 years of age, with no history of significant eye disease or any current eye disease that would affect the pharmacokinetics of cis-UCA. Subjects without any treatment-emergent adverse events during Part 1 may continue to Part 2 of the study.
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 |
|---|---|---|
| Group 1: Cis-UCA 0.5% eye drops | Experimental | Drug: cis-urocanic acid 0,5% eye drops |
| Group 2: Cis-UCA 2.5% eye drops | Experimental | Drug: cis-urocanic acid 2.5% eye drops |
| Group 3: Placebo for cis-UCA, eye drops | Placebo comparator | Drug: Placebo for cis-UCA, eye drops |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Informed consent obtained prior to any screening procedure
- Caucasian male or female subject
- Age 18-65 y
- Weight at least 45 kg
- Corrected visual acuity > 20/25 in both eyes
Key exclusion criteria (17 listed)
- History of ocular surgery, trauma, or chronic ocular disease
- Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day
- Any ocular abnormalities or ocular symptoms (defined as a non-zero score on assessment scales)
- Use of ocular agents (including all types of eye drops) within the past month prior to the first dosing day or anticipated use of ocular agents during the study period
- Use of systemic or inhaled nasal or pulmonary corticosteroids within the past month prior to the first dosing day
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-urocanic acid 0,5% eye dropsone drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2 | Drug | Group 1: Cis-UCA 0.5% eye drops |
| cis-urocanic acid 2.5% eye dropsone drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2 | Drug | Group 2: Cis-UCA 2.5% eye drops |
| Placebo for cis-UCA, eye dropsone drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2 | Drug | Group 3: Placebo for cis-UCA, eye drops |
Primary outcome
IER (Institute of Eye Research) grading scale evaluates bulbar conjunctival redness, lid redness and corneal staining and extent
Time frame: 36 days
5 secondary outcomes
Ocular comfort rating
Time frame: 36 days
Early Treatment Diabetic Retinopathy Study table, a visual acuity test
Time frame: 36 days
Anterior chamber cells and flare using SUN Working Group Grading Schemes
Time frame: 36 days
Ocular pressure
Time frame: 36 days
Schirmer's test
Time frame: 36 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 17 May 2012.
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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.
Kai Kaarniranta, Professor principal investigator
Kuopio University Hospital, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cis-urocanic acid 0,5% eye drops and cis-urocanic acid 2.5% eye drops in people with Dry Eye, run by Laurantis Pharma, Ltd. at 1 site in Finland.
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 16 inclusion and 17 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 17 May 2012. 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 Finland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
IER (Institute of Eye Research) grading scale evaluates bulbar conjunctival redness, lid redness and corneal staining and extent (time frame: 36 days). 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 17 May 2012.