Safety, Tolerability and Pharmacokinetics of 0.5% and 2.5% Cis-UCA Eye Drops in Adult Healthy Volunteers (Phase I)

NCT01476332 | Completed Phase 1

• 2 other identifiers: CL110012011-004283-30
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Keywords

eyes; cis-urocanic acid; safety; tolerability; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• IER (Institute of Eye Research) grading scale evaluates bulbar conjunctival redness, lid redness and corneal staining and extent

  36 days

Secondary Outcomes (5)

• Ocular comfort rating

  36 days

• Early Treatment Diabetic Retinopathy Study table, a visual acuity test

  36 days

• Anterior chamber cells and flare using SUN Working Group Grading Schemes

  36 days

• Ocular pressure

  36 days

• Schirmer's test

  36 days

Study Arms (3)

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

Interventions

cis-urocanic acid 0,5% eye drops DRUG

one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2

Group 1: Cis-UCA 0.5% eye drops

cis-urocanic acid 2.5% eye drops DRUG

one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2

Group 2: Cis-UCA 2.5% eye drops

Placebo for cis-UCA, eye drops DRUG

one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2

Group 3: Placebo for cis-UCA, eye drops

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Laurantis Pharma, Ltd.: lead
• Kuopio University Hospital: collaborator

Study Sites (1)

Kuopio University Hospital, Department of Ophthalmology

Kuopio, 70200, Finland

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Kai Kaarniranta, Professor

  Kuopio University Hospital, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

FI (1)