Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests

NCT04125134 | Terminated Phase 4 FDA Drug

• 1 other identifier: 13363
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

Dry Eye; artifical tear

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (5)

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

  4 weeks

• Change in Schirmer test from visit 1 to visit 2

  4 weeks

• Change in meibomian gland expression from visit 1 to visit 2

  4 weeks

• Change in proparacaine challenge test from visit 1 to visit 2

  4 weeks

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

  4 weeks

Study Arms (2)

Hypertonic Saline Responders

EXPERIMENTAL

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.

Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops

Hypertonic Saline Non-responders

EXPERIMENTAL

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.

Drug: Preservative-free Refresh Optive Advanced Lubricant Eye Drops

Interventions

Preservative-free Refresh Optive Advanced Lubricant Eye Drops DRUG

over the counter artificial tear

Hypertonic Saline Non-responders; Hypertonic Saline Responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center-New England Eye Center

Boston, Massachusetts, 02111, United States

Location

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MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Stephanie Cox, OD

  Tufts Medical Center New England Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 14, 2019
• Study Start: October 3, 2019
• Primary Completion: October 11, 2024
• Study Completion: July 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)