Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSouthern College of Optometry
About this trial
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
This trial does not accept healthy volunteersQualifiers
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..
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Acoltremon
DrugParticipants will be provided with Acoltremon or TRYPTYR to determine whether or not it is an effective medication to help alleviate symptoms associated with dry eye disease
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: TRYPTYRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean change from baseline in IDEEL-QoL Work scores at 28 days.
the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr
Time frame
1 monthSecondary outcomes
1
Mean change from baseline in IDEEL-QoL Work scores at 14 days.
the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr
Time frame
14 daysSponsors and contacts
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Source ClinicalTrials.gov