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

Tufts University

Status and phase: Terminated; Phase 4

Conditions: Dry Eye

Treatments: Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops

Study type: Interventional

Funder types: Other

Identifiers

NCT04125134

13363

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Hypertonic Saline Responders

Experimental group

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.

Treatment:

Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops

Hypertonic Saline Non-responders

Experimental group

Description:

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.

Treatment:

Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops