Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45-64
SponsorSouthern College of Optometry
About this trial
The goal of this clinical trial is to determine how Qlosi™ (pilocarpine HCL ophthalmic solution) 0.4%impacts the quality of life of participants with presbyopia by using a battery of validated and investigator-developed instruments
* Improvement in presbyopic symptoms as measured with the Near Activity Visual Questionnaire-Presbyopia (NAVQ-P) when using Qlosi™ at week 4 compared to baseline (continuous variable). * Improvement in presbyopic symptoms as measured with the Visual Quality of Life with Time Survey (VisQualT) questionnaire when using Qlosi™ at week 4 compared to baseline.
Eligibility criteria
Qualifiers
Subjects who are 45-64 years old (inclusive) at the time of screening.
Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed.
Be able and willing to follow all instructions and attend study visits.
Have text messaging capabilities on their phone.
Disqualifiers
Known hypersensitivity to any ingredient in the study drops.
Any active ocular condition that may confound study results (e.g., dry eye, allergy, conjunctivitis, ocular infection).
Any use of prescription eye drops 1 week before screening or during the study.
Any past use of the study drops.
Trial design
Treatments tested in this trial
- pilocarpine HCL ophthalmic solution
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov