Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

Phase 4

Recruiting

• Conditions: Dry Eye
• Interventions: Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops

• Registration Number: NCT04125134
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-03
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypertonic Saline Non-responders	Preservative-free Refresh Optive Advanced Lubricant Eye Drops	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.
Hypertonic Saline Responders	Preservative-free Refresh Optive Advanced Lubricant Eye Drops	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.

Primary Outcome Measures

Name	Time	Method
Change in SANDE severity score response from visit 1 to visit 2	4 weeks	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

Name	Time	Method
Change in Schirmer test from visit 1 to visit 2	4 weeks	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 hypertonic saline response test from visit 1 to visit 2	4 weeks	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.
Change in meibomian gland expression from visit 1 to visit 2	4 weeks	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	4 weeks	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 tear break up time from visit 1 to visit 2	4 weeks	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.

Trial Locations

Locations (1)

Tufts Medical Center-New England Eye Center; 🇺🇸 Boston, Massachusetts, United States