CompletedNot Applicable

Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

United States92 participantsStarted 2023-08-14

Plain-language summary

The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

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.

Key Inclusion Criteria: * Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * Able to be fit with and wear contact lenses within the available range of sphere \& cylinder power and axes. * Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening. * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months). * Other exclusion criteria may apply.

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.

What they're measuring

Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion

Timeframe: Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.

Trial details

NCT IDNCT05959200

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-23

Results submitted2024-10-15

View on ClinicalTrials.gov More Ametropia trials

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.