Switching From Restasis to TRYPTYR
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSouthern College of Optometry
About this trial
Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.
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 0.003%
DrugParticipants who are using restasis will be switched to acoltremon 0.003%
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: acoltremon 0.003%.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1
schirmers strip wetting/time will be measured between pre and post drop. With quicker wetting with greater voulme being considered better.
Time frame
1 daySecondary outcomes
1
Change in SPEED scores
participants will complete the standardized speed questionnaire at baseline and at 28 days. To determine improvement, lower speed scores are considered better.
Time frame
28 days2
Change in SPEED scores
participants will complete the standardized speed questionnaire at baseline and at 14 days. To determine improvement, lower speed scores are considered better.
Time frame
14 daysLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: