Ocular PainEarly Phase 1NCT06085352
Evaluate the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing PRK Procedure
A Early Phase 1 study testing TetraLens bandage contact lens in people with Ocular Pain, run by Vance Thompson Vision at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Pain
- What is being tested?
- TetraLens bandage contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to 25 Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: An Investigator Initiated, Randomized, Single Center Clinical Study to Evaluate the Safety, Efficacy Using the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens Undergoing a Photorefractive Keratotomy Procedure (PRK)
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)
Read the 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.
- Conditions
- Ocular Pain
- Being tested
- TetraLens bandage contact lens, Control Acuvue Oasys Bandage contact Lens
- Keywords
- ocular pain
- Medical subject headings
- Eye Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraLens bandage contact lensDrug
Methafilcon-A contact lens eluding tetracaine ophthalmic solution
Control Acuvue Oasys Bandage contact LensDevice
Standard of care bandage contact lens
| Study group | Role | What they receive |
|---|---|---|
| Receive Investigational TetraLens BCL | Experimental | At random, one eye will receive the contact lens that contains the tetracaine HCL Receives: Drug: TetraLens bandage contact lens |
| Receive standard bandage contact lens | Sham comparator | At random, one eye will receive the standard of care bandage contact lens Receives: Device: Control Acuvue Oasys Bandage contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of TetraLens BCL in the management of pain following surgical procedures
Cumulative number of daily pain medications up to Day 6 post-operative
Measured: 6 days post-operative
Safety of TetraLens BCL
Corneal wound healing (re-epithelization)
Measured: 6 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start26 Jun 2023
- Primary completion31 Dec 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vance Thompson, MD, Principal investigator, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085352
- Sponsor's protocol ID
- USPFOS-01
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated, Randomized, Single Center Clinical Study to Evaluate the Safety, Efficacy Using the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens Undergoing a Photorefractive Keratotomy Procedure (PRK)
- ClinicalTrials.gov ID
- NCT06085352
- Acronym / sponsor ID
- USPFOS-01
- Conditions
- Ocular Pain
- Keywords
- ocular pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive Investigational TetraLens BCL | Experimental | Drug: TetraLens bandage contact lensAt random, one eye will receive the contact lens that contains the tetracaine HCL |
| Receive standard bandage contact lens | Sham comparator | Device: Control Acuvue Oasys Bandage contact LensAt random, one eye will receive the standard of care bandage contact lens |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetraLens bandage contact lensMethafilcon-A contact lens eluding tetracaine ophthalmic solution | Drug | Receive Investigational TetraLens BCL |
| Control Acuvue Oasys Bandage contact LensStandard of care bandage contact lens | Device | Receive standard bandage contact lens |
Primary outcome
Efficacy of TetraLens BCL in the management of pain following surgical procedures
Time frame: 6 days post-operative
Cumulative number of daily pain medications up to Day 6 post-operative
Safety of TetraLens BCL
Time frame: 6 days post-operative
Corneal wound healing (re-epithelization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vance Thompson, MD principal investigator
Vance Thompson Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TetraLens bandage contact lens in people with Ocular Pain, run by Vance Thompson Vision at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of TetraLens BCL in the management of pain following surgical procedures (time frame: 6 days post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.