Dry Eye Syndrome (DES)
Conditions
Keywords
dry eye syndrome, ophthalmic solution, lubrication
Brief summary
The objective of this 2-part study is to assess the safety and tolerability of the new ocular lubricating drop ABR2 during short-term use in subjects for the temporary relief of ocular discomfort due to dryness of the eye. In Part 1, participant will receive 1 drop of ABR2 in one eye and through assessments over a 1-hour period. In Part 2, participant will use 1 drop of ABR2 at least two times a day for 28-day period (may use up to 4 times a day as needed) This is a single arm, open label study with no placebo or comparative arm.
Detailed description
Part 1 has a total of 2 scheduled visits, including Screening and Treatment visit. Participants will attend Part 1 for a total of 3.0 hours. Part 2 has a total of 6 scheduled visits, including the Screening, baseline & dispense visit, day 3, 1-week, 2-week, and 4-week Follow Up. Participants will attend Part 2 for a total of 6.5 hours.
Interventions
DRUGPart 2 ABR2 At least twice a day for 28 days
Use ABR2 at least BID, up to QID for 28 days
DRUGPart 1: ABR2 single dose in one eye
Receive a single dose in one eye only
Sponsors
Pleryon Therapeutics (Hangzhou) Limited
University of Waterloo School of Optometry and Vision Science
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are at least 18 years of age and have capacity to volunteer 2. Are able to read (Part 2 only); 3. Have signed an information and consent letter; 4. Are willing to follow instructions and maintain the appointment schedule; 5. Are willing to refrain from contact lens wear throughout the study period; 6. Have a best corrected visual acuity of +0.20 LogMAR or better in each eye; 7. Have an OSDI score ≥13 AND at least one of the following signs in at least one eye: Non-invasive tear film break-up time (NITBUT) \< 10 sec, AND/OR ocular surface staining (\> 5 corneal spots, and/ or \> 9 conjunctival spots)
Exclusion criteria
1. Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days; 2. Have a known active ocular disease and/ or infection with the exception of dry eye disease; 3. Have any slit lamp findings that would contraindicate use of the study product; 4. Have a systemic condition that would contraindicate use of the study product; 5. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 6. Have undergone refractive error surgery or intraocular surgery within the last 12 months; 7. Have any known sensitivity or allergy to the diagnostic sodium fluorescein or to any ingredients in the study product; 8. Are using ocular lubricating eye drops more than twice per day on a typical day over the past month (Part 2 only); 9. Are an employee of the Centre for Ocular Research \& Education directly involved in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | At the end of Part 1: 60 minutes after single drop monocular instillation and At the end of Part 2 (after 28 days of bilateral use) | Number of adverse events associated with the use of ocular eye drop. Example of adverse events may include, severe conjunctival and palpebral hyperemia, hypersensitivity, allergic reaction, eyelid edema, and photophobia. |
Countries
Canada
Contacts
CONTACTCORE Studies
CONTACTUlli Stahl, PhD
STUDY_CHAIRCharis Lau, PharmD, OD
Pleryon Therapeutics
PRINCIPAL_INVESTIGATORJill Woods, MSc, MCOptom
Centre for Ocular Research & Education, University of Waterloo
Outcome results
None listed