NCT07266948 Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
| NCT ID | NCT07266948 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Southern College of Optometry |
| Condition | Dry Eye |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2026-01-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 years of age. * Have a history of DED for at least the past 6 months. * Are currently using Restasis as directed by their eye care provider for ≥1 month. * Participant intends to stop Restasis in the near future because and expressed dissatisfaction with effectiveness of Restasis in reducing dry eye symptoms.. * Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score \[≥2 to \<10 mm/5 min\]) at Screening/Baseline. * Have corrected distance visual acuity of 20/100 or better. * Willing to discontinue contact lens wear throughout the study. Exclusion Criteria: * Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome). * Have a history of ocular surgery within the past 12 months. * Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related. * Punctal plug