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TetraLens for Post-PRK Eye Pain

Q: Is participation in this experiment currently available to qualified individuals?

<p>As verified by clinicaltrials.gov, this trial is actively recruiting. The first posting was on June 26th 2023 and the information was most recently updated on October 12th of that same year.</p>

Q: How many participants have enrolled in this research project?

<p>Affirmative. The information hosted on clinicaltrials.gov declares that this research, which was first published on June 26th 2023, is actively seeking volunteers. 10 participants are necessary at a single medical facility.</p>

Phase < 1

Recruiting

Led By Vance Thompson, MD

Research Sponsored by Vance Thompson Vision

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥ 22 years of age at time of surgery

Patients who have been cleared to undergo PRK procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 days post-operative

Awards & highlights

Study Summary

This trial will study the safety, efficacy, and comfort of a special contact lens to manage pain after a type of eye surgery. Participants will wear the lens for 6 days and report pain and comfort.

Who is the study for?

This trial is for patients over 22 years old who are cleared for PRK eye surgery and can wear a bandage contact lens in each eye, one week apart. They must be able to attend follow-up visits and not have dry eye disease, previous complications with PRK, or certain systemic disorders that affect healing.Check my eligibility

What is being tested?

The study tests the TetraLens bandage contact lens's ability to manage pain and improve comfort after PRK surgery compared to a standard Acuvue Oasys lens. Patients will document their pain levels and oral painkiller use while wearing the lenses for six days post-operation.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing the lenses, allergic reactions to Tetracaine (in those with known allergies), or issues related to delayed corneal healing due to medication interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 22 years old or older.

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I have been approved for the PRK eye surgery.

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I can attend all required follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 days post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 days post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 days post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of TetraLens BCL with respect to adverse reactions

To assess the efficacy of TetraLens BCL in the management of pain following surgical procedures

Secondary outcome measures

Exploratory efficacy of Tetralens BCL management of pain and contact lens tolerability

Safety of Tetralens BCL

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Receive Investigational TetraLens BCLExperimental Treatment1 Intervention

At random, one eye will receive the contact lens that contains the tetracaine HCL

Group II: Receive standard bandage contact lensPlacebo Group1 Intervention

At random, one eye will receive the standard of care bandage contact lens

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vance Thompson VisionLead Sponsor

8 Previous Clinical Trials

242 Total Patients Enrolled

Vance Thompson, MDPrincipal InvestigatorVance Thompson Vision

1 Previous Clinical Trials

121 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this experiment currently available to qualified individuals?

"As verified by clinicaltrials.gov, this trial is actively recruiting. The first posting was on June 26th 2023 and the information was most recently updated on October 12th of that same year."

Answered by AI

How many participants have enrolled in this research project?

"Affirmative. The information hosted on clinicaltrials.gov declares that this research, which was first published on June 26th 2023, is actively seeking volunteers. 10 participants are necessary at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluate the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing PRK Procedure

2023. "Evaluate the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing PRK Procedure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085352.

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