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| ID | Type | Description | Link |
|---|---|---|---|
| P/892/25/PL | Other Identifier | Centre for Ocular Research & Education |
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| Name | Class |
|---|---|
| University of Waterloo School of Optometry and Vision Science | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Part 1 Participants |
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| Part 2 | Experimental | Part 2 Participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 2 ABR2 At least twice a day for 28 days | Drug | Use ABR2 at least BID, up to QID for 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 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. | 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Ocular Comfort, Stinging/Burning Sensation and Vision | Participants will be asked to provide subjective ratings of ocular comfort, stinging/burning sensation and vision based on 0-100 rating scale. | Part 1: Immediately after drop instillation, 10 minutes, 30 minutes and 60 minutes post drop instillation. Part 2: Upon waking and at the end of day weekly for 4 weeks (Home Questionnaire) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CORE Studies | Contact | 519-888-4742 | corestudies@uwaterloo.ca | |
| Ulli Stahl, PhD | Contact | 519-888-4742 | ustahl@uwaterloo.ca |
| Name | Affiliation | Role |
|---|---|---|
| Charis Lau, PharmD, OD | Pleryon Therapeutics | Study Chair |
| Jill Woods, MSc, MCOptom | Centre for Ocular Research & Education, University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo | Recruiting | Waterloo | Ontario | N2L 3G1 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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Small sample size re-identification risk and limited infrastructure for external data access.
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Part 1: ABR2 single dose in one eye |
| Drug |
Receive a single dose in one eye only |
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| Signs of ocular dryness - Non-invasive tear film break up time (NITBUT) | Non-invasive tear film break up time (NITBUT) will be performed to examine signs of ocular dryness. | Part 1: Baseline and 60 minutes after a drop of ABR2 application. Part 2: Baseline, 2 week, and 4 week after ABR2 use |
| High Contrast High Luminance (HCHI) LogMAR Visual Acuity | Monocular and binocular HCHI VA | Part 1: Baseline, immediate, 5 minutes, 10 minutes, 30 minutes and 60 minutes after drop application Part 2: Baseline, day 3, 1-week, 2-week and 4-week follow up |