Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT07266948

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here