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Completed

NCT Number: NCT05497479

Study Evaluating Techniques for Measuring Tear Production

This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eye Research Foundation

Newport Beach, California, 92663, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1
  • Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min
  • Within the last year from Visit 1, have documented symptoms of DED
  • Corrected Visual Acuity (Snellen) 20/200 or better in both

Exclusion criteria

  • Use of artificial tears within 2 hours prior to Visit 1
  • Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period.
  • Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1
  • Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
  • Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study.

Treatment and study plan

0.003% AR-15512 to be administered in both eyes

Drug

Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512

Vehicle to be administered in both eyes

Drug

Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle

Primary outcomes

  1. Unanesthetized Schirmer test

    Time frame: Day 1

    Proportion of subjects ≥ 10 mm increase in unanesthetized Schirmer score

    Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.

  2. Unanesthetized Schirmer test

    Time frame: Day 1

    Mean change in Unanesthetized Schirmer score

    Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.

  3. Unanesthetized Schirmer test

    Time frame: Day 1

    Mean Unanesthetized Schirmer score

    Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.

  4. Anesthetized Schirmer test

    Time frame: Day 1

    Proportion of subjects ≥ 10 mm increase in anesthetized Schirmer score

    Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.

  5. Anesthetized Schirmer test

    Time frame: Day 1

    Mean change in anesthetized Schirmer score.

    Schirmer strips placed without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.

  6. Anesthetized Schirmer test

    Time frame: Day 1

    Mean anesthetized Schirmer score

    Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1 Study Evaluating Techniques for Measuring Tear Production

Acronym: MTP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 11, 2022
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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