Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEye Research Associates, LLC
About this trial
Dry Eye Disease is a multifaceted condition which has symptoms such as eye dryness, burning, and stinging sensation in the eyes. As well as clinical diagnosis such as a decreased ability to create tear film. Despite improvements in Contact Lenses (CL) DED still is responsible for a large percentage of CL dropouts due to discomfort. Thus, the purpose of this study is to determine if acoltremon 0.003% can improve the frequency and severity of DED symptoms in CL wearers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Adult subjects who are ≥18 years of age.
Best corrected CL visual acuity of 0.1 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/25).
Willing to wear a new pair of CLs to the baseline study visit.
Daily, soft, frequent replacement CL wearer (daily disposable, bi-weekly, or monthly CLs).
Disqualifiers
Any history of acoltremon 0.003% use.
Are currently an overnight CL wearer.
Are currently hard or scleral CL wearers.
Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
Trial design
Design model
Single group
Treatments tested in this trial
acoltremon 0.003%
DrugAcoltremon 0.003% (TRYPTYR; Alcon Laboratories; Fort Worth, TX, USA) was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor potential melastatin (TRPM8) agonist for the treatment of DED. Acoltremon 0.003% is dosed twice a day
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: acoltremon 0.003%Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Eye Dryness Score (VAS) at 4 weeks compared to baseline
participants will be asked to evaluate their eye dryness using a VAS scale with higher numbers indicating greater comfort.
Time frame
1 monthSecondary outcomes
1
Eye Dryness Score (VAS) at 2 weeks compared to baseline
participants will be asked to complete an eye dryness visual analog scale with higher numbers indicating greater comfort
Time frame
two weeks2
CL End of day comfort VAS
participants will be asked to complete a contact lens comfort visual analog scale with higher numbers indicating greater comfort
Time frame
4 weeks3
CL End of day comfort VAS
participants will be asked to complete a contact lens comfort visual analog scale with higher numbers indicating greater comfort
Time frame
2 weeks4
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
participants will be asked to complete the CLDEQ-8 questionnaire with lower scores indicating more comfort
Time frame
1 monthLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Eye Research Associates, LLC
Lead sponsor
Southern College of Optometry
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: