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Chloroprocaine Ophthalmic Gel for Antiseptic and Local Anesthesia
Phase 4
Recruiting
Research Sponsored by Harrow Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 5 minutes after baseline.
Awards & highlights
Study Summary
This trial tests if a gel prevents an antiseptic from killing bacteria on the eye surface.
Who is the study for?
This trial is for adults over 18 who can legally consent to participate. It's not suitable for those with recent eye trauma, eyelid abnormalities, active inflammation or infection in the eyes, a history of certain eye conditions within the last 3 months, or if pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests whether Chloroprocaine ophthalmic gel 3% interferes with the germ-killing action of povidone-iodine on the eye surface. Participants will receive this local anesthetic to see if it affects antiseptic effectiveness.See study design
What are the potential side effects?
Potential side effects may include temporary discomfort in the eye where the gel is applied, possible allergic reactions to ingredients in the gel, and less effective bacterial killing by povidone-iodine due to interference from the gel.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 5 minutes after baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 5 minutes after baseline.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in colony forming units
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Chloroprocaine ophthalmic gel 3%Experimental Treatment1 Intervention
FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.
Group II: Tetracaine ophthalmic solution 0.5%Active Control1 Intervention
FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.
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Who is running the clinical trial?
Harrow IncLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active eye inflammation as assessed by a doctor.I have had a serious eye injury.I have not had an eye infection in the last 3 months.I am over 18 years old.I haven't had eye surgery in the last 3 months or any that would affect this study.I am not under 18, pregnant, breastfeeding, nor planning to become pregnant during the study.You have vision in only one eye.I have been diagnosed with a severe eyelid condition.I do not have an active eye infection.I have moderate to severe eye allergies.
Research Study Groups:
This trial has the following groups:- Group 1: Chloroprocaine ophthalmic gel 3%
- Group 2: Tetracaine ophthalmic solution 0.5%
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Chloroprocaine ophthalmic gel 3% for medicinal use?
"Chloroprocaine ophthalmic gel 3% is approved and has a safety score of 3 on our metric scale. This determination was made due to the fact that this medical trial is in Phase 4, which attests to its efficacy and relative security."
Answered by AI
Is the eligibility for this trial restricted to participants aged 45 or under?
"The rules governing patient admittance to this clinical trial mandate that applicants must be between 18 and 99 years old."
Answered by AI
Are there still opportunities for potential participants to join this research?
"According to clinicaltrials.gov, this medical study is not actively recruiting patients as the trial was last edited on June 28th 2023. Despite that, there are still 34 other open trials currently enrolling individuals."
Answered by AI
Is it possible for me to become involved in this clinical experiment?
"Being antiseptic is a prerequisite to be considered for this trial. Additionally, the age range should fall between 18 and 99 years old. Currently, 60 participants are being sought after by investigators."
Answered by AI
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