Health TrialsbyHealthPanel

Quality of Life in Presbyopic Patients Who Are Treated With Qlosi

ConditionsPresbyopiaGlassesDry Eye
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • pilocarpine HCL ophthalmic solution

    Drug

    Qlosi will be given to participants and quality of life will be determined.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: QlosiExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Near Visual Acuity Questionnaire-Presbyopia

• 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). In which higher scores are better.

Time frame
1 month

Secondary outcomes

1

Visual Quality of Life with Time Survey (VisQualT)

• 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

Time frame
1 month
2

Improvement in overall visual acuity score

• Improvement in presbyopic symptoms as measured with the overall quality of life VAS when using Qlosi™ at week 4 compared to baseline. In which higher scores are better

Time frame
1 month
3

Investigator developed survey

• Improvement in presbyopic symptoms as measured with the Investigator-Developed Likert Survey when using Qlosi at week 4 compared to baseline. In which positive answers such as strongly agree are better.

Time frame
1 month
4

Text message surveys

• Real-time text messaging to subjects on each day of treatment to identify time to treatment onset post-drop application (minutes). In which lower scores are better.

Time frame
1 day, 1 week, 1 month

Other outcomes

Sponsors and contacts

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

Southern College of Optometry

Lead sponsor

Source ClinicalTrials.gov
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