Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel (NCT03994406) | Clinical Trial Compass
CompletedPhase 2
Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical Gel
United States30 participantsStarted 2019-06-27
Plain-language summary
This study compares contact lens comfortable wear duration, and signs and symptoms of contact lens discomfort, test versus control.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female of any race ≥18 years of age at Visit 1 Screening.
. Has provided verbal and written informed consent.
. Be able and willing to follow instructions, including participation in all study assessments and visits.
. Has been wearing soft contact lens in both eyes at least 2 days per week for at least a month.
. Duration of comfortable lens wear daily is less than desired.
. Suffers from at least two other symptoms while wearing lens with contact lens discomfort of grade 2 or higher:
. Dryness.
. Grittiness
Exclusion criteria
. BCVA at baseline \<20/40.
. Wearing contact lens only in one eye.
. Wearers of the following contact lenses: Extended wear, prosthetic, scleral, and intracorneal gas permeable.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Pregnant women or women of childbearing potential who are not using contraception.
. Diagnosis of the following autoimmune diseases: Addison's disease, Grave's disease, Hashimoto's thyroiditis, lupus, and Sjogren's syndrome.
. Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such dystrophies, infections, etc.
. Has a condition or be in a situation that, the opinion of the investigator, that may interfere significantly with the subject's participation in the study. No active ocular condition or disease.
. Has a known adverse reaction and/or sensitivity to either study drug or its components.