Actively Recruiting
Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
Led by Southern College of Optometry · Updated on 2025-12-05
40
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults ≥18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score ≥40) will be recruited. Subjects will have an abnormal Schirmer test of \<10 mm/5 min. Subjects will also be required to score ≤70 on the IDEEL Quality of Life (QoL) Work domain to ensure that their DED symptoms are significantly impacting their ability to do work.9 Subjects will be required to have corrected distance visual acuity of 20/32 (0.2 logMAR) or better.
CONDITIONS
Official Title
Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 75 years of age
- History of dry eye disease for at least 6 months
- Currently using Restasis as directed for at least 1 month
- Intend to stop using Restasis soon due to dissatisfaction with its effectiveness
- Symptomatic with Eye Dryness VAS Score of 50 or higher and SPEED score of 7 or higher
- Abnormal Schirmer test score between 2 and less than 10 mm/5 min at screening
- Corrected distance visual acuity of 20/100 or better
- Willing to stop wearing contact lenses during the study
You will not qualify if you...
- Have systemic health conditions affecting tear film such as primary or secondary Sjögren's syndrome
- History of ocular surgery within the past 12 months
- History of severe eye injury or active eye infection/inflammation not related to dry eye
- Punctal plugs placed less than 3 months ago or Lacrifill treatment longer than 5 months
- Ever used Accutane or currently using other ocular medications (except Restasis) without a 1-week washout
- Use of artificial tears within 2 hours before baseline or during the study
- Are pregnant or breastfeeding
- Had meibomian gland physical treatment within 1 month before enrollment
- Any condition or situation that may risk safety, confound results, or interfere with participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Kannar Eye Care
Pittsburg, Kansas, United States, 66762
Actively Recruiting
2
Complete Eye Care of Medina
Medina, Minnesota, United States, 55340
Actively Recruiting
3
The Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
Research Team
C
Chris Lievens, OD
CONTACT
Q
Quentin Franklin, BS, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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