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

Primary Purpose

Ocular Pain Following Bilateral Photorefractive Keratotomy (PRK)

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
TetraLens bandage contact lens
Control Acuvue Oasys Bandage contact Lens
Sponsored by
Vance Thompson Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Pain Following Bilateral Photorefractive Keratotomy (PRK) focused on measuring ocular pain

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients ≥ 22 years of age at time of surgery patients who have been cleared to undergo PRK procedure Patients who are willing to have procedure in both eyes, at least 1 week apart randomized to receive the product under investigation in one eye and control lens in other eye Patients are able to wear bandage contact lens for 1 week Patients able to attend all follow-up study visits Exclusion Criteria: Patients who have experienced complications during PRK procedures Women of childbearing potential that are pregnant, nursing, or planning a pregnancy, and are not using effective methods of contraception. Effective contraception methods include: Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. (Occasional abstinence is not an effective contraceptive method). Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before Baseline. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment Male sterilization (at least 6 months prior to Baseline). For female subjects in the study, the vasectomized male partner should be the sole partner for that subject Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS). Known allergy to Tetracaine or contraindications for its use Significant anisometropia of greater than 2 diopters of manifest refraction spherical equivalent (MRSE) between eyes or hyperopes Subjects having a history of previous eye surgery Subjects with planned MRSE treatment of greater than 6.00D Subjects with uncontrolled dry eye disease in the opinion of the investigator History of systemic disorder such as diabetes, connective tissue disorder (systemic lupus erythematosis, rheumatoid arthritis, Sjögren syndrome, mucous membrane pemphigoid), thyroid disease, or immunosuppressive disorders (Human Immunodeficiency Virus [HIV], long-term steroid use, transplant recipient), that may affect post-operative healing Corneal disease that may affect outcomes including keratoconus, form fruste keratoconus, limbal stem cell deficiency, pellucid marginal degeneration, contact lens warpage, and/or herpes keratitis Use of chronic glaucoma and or hypotensive topical medications than in the view of the investigator could cause epitheliopathy and affect the rate of re-epithelization Visually significant cataract Other pathology of the cornea or anterior segment including lagophthalmos, blepharitis, anterior membrane dystrophy, corneal neuropathy, recurrent erosions and/or scarring that would affect wound re-epithelization Use of medications that may affect and/or decrease the rate of corneal healing [e.g., systemic and or topical medications (corticosteroids, antimetabolites such as mitomycin) and/or antiviral medications] and or recent use (within the past 6 months) of isotretinoin, amiodarone or any medications that can affect corneal integrity Any other factors that in the opinion of the investigator could put the subject at safety risk

Sites / Locations

  • Vance Thompson VisionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Receive Investigational TetraLens BCL

Receive standard bandage contact lens

Arm Description

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

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

Outcomes

Primary Outcome Measures

To assess the efficacy of TetraLens BCL in the management of pain following surgical procedures
Cumulative number of daily pain medications up to Day 6 post-operative
Safety of TetraLens BCL with respect to adverse reactions
Cumulative rate of adverse reactions and time to corneal wound healing (re-epithelization)

Secondary Outcome Measures

Exploratory efficacy of Tetralens BCL management of pain and contact lens tolerability
Evaluate reported pain using Ocular Pain Assessment Survey, evaluate contact lens comfort and awareness
Safety of Tetralens BCL
Assess safety of TetraLens BCL using exploratory measures of rate of adverse events, corneal thickness, slit-lamp evaluation, rate of contact lens related deficiencies

Full Information

First Posted
September 26, 2023
Last Updated
October 12, 2023
Sponsor
Vance Thompson Vision
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1. Study Identification

Unique Protocol Identification Number
NCT06085352
Brief Title
Evaluate the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing PRK Procedure
Official Title
An Investigator Initiated, Randomized, Single Center Clinical Study to Evaluate the Safety, Efficacy, and Wearability Using the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing a Photorefractive Keratotomy Procedures (PRK)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vance Thompson Vision

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to determine the safety, efficacy, and comfort of the investigational TetraLens bandage contact lens in patients who have undergone photorefractive keratectomy (PRK). The main question[s] it aims to answer are: Understand benefit of managing pain following the surgical procedure Understand the safety of the Tetralens Participants will be asked to wear theTetraLens BCL in one eye for 6 days post-operatively and: document the daily quantity of oral analgesics needed and report ocular pain and contact lens comfort. Researchers will compare the study lens in one eye to a control lens in the contralateral (other eye)
Detailed Description
The safety and efficacy of the methafilcon A and tetracaine HCL components of the TetraLens BCL have safety and efficacy profiles that are well established. This study aims to obtain the initial assessment of the safety efficacy and wearability of the TetraLens BCL for use a therapeutic bandage contact lens for short-term topical pain relief following ocular surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Pain Following Bilateral Photorefractive Keratotomy (PRK)
Keywords
ocular pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Receive Investigational TetraLens BCL
Arm Type
Experimental
Arm Description
At random, one eye will receive the contact lens that contains the tetracaine HCL
Arm Title
Receive standard bandage contact lens
Arm Type
Sham Comparator
Arm Description
At random, one eye will receive the standard of care bandage contact lens
Intervention Type
Drug
Intervention Name(s)
TetraLens bandage contact lens
Intervention Description
Methafilcon-A contact lens eluding tetracaine ophthalmic solution
Intervention Type
Device
Intervention Name(s)
Control Acuvue Oasys Bandage contact Lens
Intervention Description
Standard of care bandage contact lens
Primary Outcome Measure Information:
Title
To assess the efficacy of TetraLens BCL in the management of pain following surgical procedures
Description
Cumulative number of daily pain medications up to Day 6 post-operative
Time Frame
6 days post-operative
Title
Safety of TetraLens BCL with respect to adverse reactions
Description
Cumulative rate of adverse reactions and time to corneal wound healing (re-epithelization)
Time Frame
6 days post-operative
Secondary Outcome Measure Information:
Title
Exploratory efficacy of Tetralens BCL management of pain and contact lens tolerability
Description
Evaluate reported pain using Ocular Pain Assessment Survey, evaluate contact lens comfort and awareness
Time Frame
Cumulatively for 6 days post-operative
Title
Safety of Tetralens BCL
Description
Assess safety of TetraLens BCL using exploratory measures of rate of adverse events, corneal thickness, slit-lamp evaluation, rate of contact lens related deficiencies
Time Frame
Cumulative 6 days post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients ≥ 22 years of age at time of surgery patients who have been cleared to undergo PRK procedure Patients who are willing to have procedure in both eyes, at least 1 week apart randomized to receive the product under investigation in one eye and control lens in other eye Patients are able to wear bandage contact lens for 1 week Patients able to attend all follow-up study visits Exclusion Criteria: Patients who have experienced complications during PRK procedures Women of childbearing potential that are pregnant, nursing, or planning a pregnancy, and are not using effective methods of contraception. Effective contraception methods include: Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception. (Occasional abstinence is not an effective contraceptive method). Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before Baseline. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment Male sterilization (at least 6 months prior to Baseline). For female subjects in the study, the vasectomized male partner should be the sole partner for that subject Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS). Known allergy to Tetracaine or contraindications for its use Significant anisometropia of greater than 2 diopters of manifest refraction spherical equivalent (MRSE) between eyes or hyperopes Subjects having a history of previous eye surgery Subjects with planned MRSE treatment of greater than 6.00D Subjects with uncontrolled dry eye disease in the opinion of the investigator History of systemic disorder such as diabetes, connective tissue disorder (systemic lupus erythematosis, rheumatoid arthritis, Sjögren syndrome, mucous membrane pemphigoid), thyroid disease, or immunosuppressive disorders (Human Immunodeficiency Virus [HIV], long-term steroid use, transplant recipient), that may affect post-operative healing Corneal disease that may affect outcomes including keratoconus, form fruste keratoconus, limbal stem cell deficiency, pellucid marginal degeneration, contact lens warpage, and/or herpes keratitis Use of chronic glaucoma and or hypotensive topical medications than in the view of the investigator could cause epitheliopathy and affect the rate of re-epithelization Visually significant cataract Other pathology of the cornea or anterior segment including lagophthalmos, blepharitis, anterior membrane dystrophy, corneal neuropathy, recurrent erosions and/or scarring that would affect wound re-epithelization Use of medications that may affect and/or decrease the rate of corneal healing [e.g., systemic and or topical medications (corticosteroids, antimetabolites such as mitomycin) and/or antiviral medications] and or recent use (within the past 6 months) of isotretinoin, amiodarone or any medications that can affect corneal integrity Any other factors that in the opinion of the investigator could put the subject at safety risk
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Dunne
Phone
605-371-7037
Email
kristin.dunne@vancethompsonvision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elle Malmanger
Phone
605-371-7083
Email
elle.malmanger@vancethompsonvision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vance Thompson, MD
Organizational Affiliation
Vance Thompson Vision
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keeley Puls
Phone
605-371-7075
Email
keeley.puls@vancethompsonvision.com
First Name & Middle Initial & Last Name & Degree
Kristin Dunne
Phone
6053613937
Email
kristin.dunne@vancethompsonvision.com
First Name & Middle Initial & Last Name & Degree
Kayla Karpuk, OD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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