MTP: Study Evaluating Techniques for Measuring Tear Production

Sponsor

Aerie Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT05497479

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

1217.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: 0.003% AR-15512 to be administered in both eyes Drug: Vehicle to be administered in both eyes Drug: 0.003% AR-15512 to be administered in both eyes Drug: Vehicle to be administered in both eyes	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All eligible subjects will be enrolled and randomized (1:1) to one of two treatment groups: active (0.003% AR-15512) or control (AR-15512 vehicle). Following enrollment, subjects in the two treatment groups will each be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.All eligible subjects will be enrolled and randomized (1:1) to one of two treatment groups: active (0.003% AR-15512) or control (AR-15512 vehicle). Following enrollment, subjects in the two treatment groups will each be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study Evaluating Techniques for Measuring Tear Production

Actual Study Start Date :

Dec 9, 2021

Actual Primary Completion Date :

Dec 10, 2021

Actual Study Completion Date :

Dec 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment with Schirmer test with no anesthetic Both eyes will be treated.	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 Drug: Vehicle to be administered in both eyes Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle
Experimental: Treatment with Schirmer test with anesthetic Both eyes will be treated.	Drug: 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 Drug: Vehicle to be administered in both eyes Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle

Arm

Intervention/Treatment

Experimental: Treatment with Schirmer test with no anesthetic

Both eyes will be treated.

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

Drug: Vehicle to be administered in both eyes

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

Experimental: Treatment with Schirmer test with anesthetic

Both eyes will be treated.

Drug: 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

Drug: Vehicle to be administered in both eyes

Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle

Outcome Measures

Primary Outcome Measures

Unanesthetized Schirmer test [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.
Unanesthetized Schirmer test [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.
Unanesthetized Schirmer test [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.
Anesthetized Schirmer test [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.
Anesthetized Schirmer test [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.
Anesthetized Schirmer test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Research Foundation	Newport Beach	California	United States	92663

Sponsors and Collaborators

Aerie Pharmaceuticals

Investigators

Study Director: Michelle S Senchyna, PhD, Aerie Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aerie Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT05497479

Other Study ID Numbers:

21-110-A

First Posted:

Aug 11, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Eye Diseases

Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Aug 11, 2022