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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-11-01 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 plugs in place for \< 3 months and/or Lacrifill in place for \> 5 months. * Have ever used Accutane or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry, except for Restasis). * Use of artificial tears within 2 hours prior to the baseline visit or during the study. * Are pregnant or breast feeding. * Have had a physical meibomian gland treatment withing 1 month of enrollment. * Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07266948 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Dry Eye. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07266948 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07266948 currently recruiting?
Yes, NCT07266948 is actively recruiting participants. Contact the research team at clievens@sco.edu for enrollment information.
Where is the NCT07266948 trial being conducted?
This trial is being conducted at Pittsburg, United States, Medina, United States, Memphis, United States.
Who is sponsoring the NCT07266948 clinical trial?
NCT07266948 is sponsored by Southern College of Optometry. The trial plans to enroll 40 participants.