Study Evaluating Techniques for Measuring Tear Production

Dry Eye Disease Clinical Trial

— MTP  

Official title:

A Phase 1 Study Evaluating Techniques for Measuring Tear Production

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05497479
• Other study ID #: 21-110-A
• Status: Completed
• Phase: Phase 1
• Start date: December 9, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: August 2022
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 0.003% AR-15512 to be administered in both eyes
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
Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle
• 0.003% AR-15512 to be administered in both eyes
Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512
• Vehicle to be administered in both eyes
Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle

Locations

Country	Name	City	State
United States	Eye Research Foundation	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unanesthetized Schirmer test	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.	Day 1
Primary	Unanesthetized Schirmer test	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.	Day 1
Primary	Unanesthetized Schirmer test	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.	Day 1
Primary	Anesthetized Schirmer test	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.	Day 1
Primary	Anesthetized Schirmer test	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.	Day 1
Primary	Anesthetized Schirmer test	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.	Day 1