Predicting success of treatments for dry eye disease
Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests
This study is testing if preservative-free artificial tears can help people with dry eye disease feel better after four weeks of use.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tufts Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04125134 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves a single site, prospective, cross-sectional, controlled study with 66 participants diagnosed with Dry Eye Disease (DED). Participants are divided into two groups based on their response to hypertonic saline: responders and non-responders. After completing questionnaires and undergoing various dry eye tests, eligible subjects will receive preservative-free artificial tears for four weeks, followed by a follow-up visit to reassess their symptoms and test results. The goal is to evaluate the effectiveness of the artificial tears in improving dry eye symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of Dry Eye Disease and specific symptoms and test results indicating their response to hypertonic saline.
Not a fit: Patients who do not have Dry Eye Disease or those who do not meet the specific inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients suffering from dry eye disease.
How similar studies have performed: Other studies have shown promise in using similar approaches to assess treatment efficacy in dry eye disease, indicating that this methodology is not entirely novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Tufts Medical Center-New England Eye Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Cox, OD — Tufts Medical Center New England Eye Center
- Study coordinator: Nancy Gee, MPH
- Email: ngee@tuftsmedicalcenter.org
- Phone: 617-636-5489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.