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Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests (PreDICT)

Primary Purpose

Dry Eye

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Preservative-free Refresh Optive Advanced Lubricant Eye Drops

About this trial

This is an interventional other trial for Dry Eye focused on measuring Dry Eye, artifical tear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Group 1 (Hypertonic saline non-responders):

At least 18 years of age
Ability to consent
Diagnosis of Dry Eye Disease (DED) based on:
- Symptoms of DED, shown with SANDE score of 50mm or greater
- Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands
HS response result of one of the following:
- Reduction of discomfort/pain rating
- No change of discomfort/pain rating
- Increase in discomfort/pain rating score of 1 step or less

Group 2 (Hypertonic saline non-responders):

At least 18 years of age
Ability to consent
Diagnosis of DED based on:
- Symptoms of DED, shown with SANDE score 50mm or greater
- Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands
HS response result of an increase in discomfort/pain rating of greater than 1 step

Exclusion Criteria:

Presence of centralized pain as indicated by a proparacaine challenge test (PCT) of less than 50% ocular surface discomfort reduction
Unable to speak English
History of ocular surgery, corneal infection, or corneal injury within the last 3 months
Active ocular allergies or other condition that could impact the study results
Allergic to benzalkonium chloride "BAK" (an eye-drop preservative)
Changes in topical or systemic medications in the last 3 months or anticipated changes in medication during the course of treatment
Use of other topical treatments
Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study
Use of contact lenses within the last month

Sites / Locations

Tufts Medical Center-New England Eye CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Hypertonic Saline Responders

Hypertonic Saline Non-responders

Arm Description

Subjects who qualify as hypertonic saline responders will be instructed to instill 1-2 drops of preservative-free Refresh Optive Advanced Lubricant Eye Drops, which are available over the counter, into each eye twice a day for 28 days.

Subjects who qualify as hypertonic saline non-responders will be dispensed the same instructions and treatment as the Hypertonic Saline Responders. They will be instructed to instill 1-2 drops of preservative-free Refresh Optive Advanced Lubricant Eye Drops, which are available over the counter, into each eye twice a day for 28 days.

Outcomes

Primary Outcome Measures

Change in SANDE severity score response from visit 1 to visit 2

The SANDE questionnaire is a paper and pencil questionnaire consisting of two questions (1. severity of dry eye disease symptoms and 2. frequency of dry eye disease symptoms), which are answered on a continuous visual analogue scale. The severity response from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group.

Secondary Outcome Measures

Change in tear break up time from visit 1 to visit 2

The tear break up time is a measure of the stability of the tear film. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group.

Change in Schirmer test from visit 1 to visit 2

The Schirmer test is a measure of tear production. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group.

Change in meibomian gland expression from visit 1 to visit 2

Meibomian gland expression allows for a measure of the health of the meibomian glands. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group.

Change in proparacaine challenge test from visit 1 to visit 2

The proparacaine challenge test allows for a measure of the amount of peripheral neuropathic pain compared to centralized neuropathic pain. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group.

Change in hypertonic saline response test from visit 1 to visit 2

The hypertonic saline response is expected to be able to assess the severity of dry eye disease. The measurement from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group.

Full Information

NCT ID

NCT04125134

First Posted

October 9, 2019

Last Updated

March 10, 2023

Sponsor

Tufts Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04125134

Brief Title

Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

Acronym

PreDICT

Official Title

Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 3, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: Hypertonic Saline Non-Responders (33 subjects) and Hypertonic Saline Responders (33 subjects). After completion of questionnaires, the subjects will undergo Dry Eye Disease testing and functional nerve testing. Subjects who qualify will be dispensed 4 weeks of preservative free artificial tears and instructed to instill one drop into each eye twice daily. Subjects will return for a follow up visit 4 weeks later (± 4 days), during which subjects will complete the questionnaires again and the Dry Eye Disease tests and functional nerve tests will be repeated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry Eye, artifical tear

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypertonic Saline Responders

Arm Type

Experimental

Arm Description

Arm Title

Hypertonic Saline Non-responders

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Preservative-free Refresh Optive Advanced Lubricant Eye Drops

Intervention Description

over the counter artificial tear

Primary Outcome Measure Information:

Title

Change in SANDE severity score response from visit 1 to visit 2

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change in tear break up time from visit 1 to visit 2

Description

Time Frame

4 weeks

Title

Change in Schirmer test from visit 1 to visit 2

Description

Time Frame

4 weeks

Title

Change in meibomian gland expression from visit 1 to visit 2

Description

Time Frame

4 weeks

Title

Change in proparacaine challenge test from visit 1 to visit 2

Description

Time Frame

4 weeks

Title

Change in hypertonic saline response test from visit 1 to visit 2

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Group 1 (Hypertonic saline non-responders): At least 18 years of age Ability to consent Diagnosis of Dry Eye Disease (DED) based on: Symptoms of DED, shown with SANDE score of 50mm or greater Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands HS response result of one of the following: Reduction of discomfort/pain rating No change of discomfort/pain rating Increase in discomfort/pain rating score of 1 step or less Group 2 (Hypertonic saline non-responders): At least 18 years of age Ability to consent Diagnosis of DED based on: Symptoms of DED, shown with SANDE score 50mm or greater Two or more of the following objective signs in the same eye: 1. Schirmer test of 10 mm or less over 5 minutes; 2. Fluorescein tear break-up time (FTBUT) of 7 seconds or less; 3. Meibomian gland expression (MGE) grade of 2 or greater for at least 3 out of 5 glands HS response result of an increase in discomfort/pain rating of greater than 1 step Exclusion Criteria: Presence of centralized pain as indicated by a proparacaine challenge test (PCT) of less than 50% ocular surface discomfort reduction Unable to speak English History of ocular surgery, corneal infection, or corneal injury within the last 3 months Active ocular allergies or other condition that could impact the study results Allergic to benzalkonium chloride "BAK" (an eye-drop preservative) Changes in topical or systemic medications in the last 3 months or anticipated changes in medication during the course of treatment Use of other topical treatments Concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study Use of contact lenses within the last month

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nancy Gee, MPH

Phone

617-636-5489

ngee@tuftsmedicalcenter.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie Cox, OD

Organizational Affiliation

Tufts Medical Center New England Eye Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts Medical Center-New England Eye Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nancy Gee, MPH

Phone

617-636-5489

ngee@tuftsmedicalcenter.org

First Name & Middle Initial & Last Name & Degree

Stephanie Cox, OD

12. IPD Sharing Statement

Plan to Share IPD

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Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

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