Health TrialsbyHealthPanel

Evaluation of a Novel Ocular Lubricating Eye Drop

ConditionDry Eye Syndrome (DES)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPleryon Therapeutics (Hangzhou) Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are at least 18 years of age and have capacity to volunteer

Are able to read (Part 2 only);

Have signed an information and consent letter;

Are willing to follow instructions and maintain the appointment schedule;

Disqualifiers

Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days;

Have a known active ocular disease and/ or infection with the exception of dry eye disease;

Have any slit lamp findings that would contraindicate use of the study product;

Have a systemic condition that would contraindicate use of the study product;

Trial design

Design model

Single group

Treatments tested in this trial

  • Part 2 ABR2 At least twice a day for 28 days

    Drug

    Use ABR2 at least BID, up to QID for 28 days

  • Part 1: ABR2 single dose in one eye

    Drug

    Receive a single dose in one eye only

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Part 1Experimental treatment 1 intervention
Group B: Part 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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)

Secondary outcomes

Other outcomes

1

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.

Time frame
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)
2

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.

Time frame
Part 1: Baseline and 60 minutes after a drop of ABR2 application. Part 2: Baseline, 2 week, and 4 week after ABR2 use
3

High Contrast High Luminance (HCHI) LogMAR Visual Acuity

Monocular and binocular HCHI VA

Time frame
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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pleryon Therapeutics (Hangzhou) Limited

Lead sponsor

University of Waterloo School of Optometry and Vision Science

Collaborator

Source ClinicalTrials.gov
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