A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
- Conditions
- Ocular Redness
- Registration Number
- NCT06444529
- Lead Sponsor
- Alcon Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Key Inclusion Criteria:<br><br> - Capable of giving signed informed consent;<br><br> - Willing and able to follow all instructions and attend all study visits;<br><br> - Able to self-administer eye drops- in the opinion of the investigator;<br><br> - History of redness relief drop use within the last 6 months, or a desire to use<br> over-the-counter (OTC) eye drops for redness relief;<br><br> - Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of<br> medically acceptable forms of birth control throughout the study;<br><br> - Ocular health within normal limits, including best-corrected visual acuity (BCVA) of<br> 20/40 or better in each eye as measured using a Snellen chart;<br><br> - Ocular redness at baseline as specified in the protocol;<br><br> - Other protocol-specified inclusion criteria may apply.<br><br>Key Exclusion Criteria:<br><br> - Known contraindications or sensitivities to the use of any of the investigational<br> drug(s) or their components, or any other medication required by the protocol;<br><br> - Ocular surgical interventions within 6 months prior to Visit 1 or during the study;<br><br> - Ocular conditions that, in the opinion of the investigator, could affect the<br> subject's safety or study parameters (i.e., could affect ocular redness, intraocular<br> pressure, or eyelid position);<br><br> - Disallowed medications or devices as specified in the protocol;<br><br> - Planned surgery (ocular or systemic) during the study period or within 30 days after<br> the study period;<br><br> - Other protocol-defined exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1;Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1
- Secondary Outcome Measures
Name Time Method Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1;Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1;Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1