Health TrialsbyHealthPanel

Switching From Xiidra to TRYPTYR

ConditionsDry EyeDry Eyes ChronicDry Eye SyndromesEye Diseases
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorSouthern College of Optometry

About this trial

To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%.

Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years of age.

Have a history of DED for at least the past 6 months.

Are currently using Xiidra as directed by their eye care provider for ≥1 month.

Are symptomatic as determined with SPEED (≥7) and have an abnormal Schirmer test score [≥2 to <10 mm/5 min]) at Screening/Baseline. If Shirmer only qualifies for one eye, that will be the study eye. If Shirmer qualifies for both eyes, the right eye will be the study eye.

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%

    Drug

    Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: acoltremonExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1

The Schirmer's strip wetting time/quantity will be measured before and after the drop with quicker and more wetting me considered better.

Time frame
1 day

Secondary outcomes

1

Change in standardized speed scores

The standardized speed scores will be measured to determine change from baseline to 28 days with lower scores being better.

Time frame
28 days
2

2 week change in standardized speed scores

The standardized speed scores will be measured to determine change from baseline to 14 days with lower scores being better.

Time frame
14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southern College of Optometry

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: