Refractive Error - Myopia SimpleNCT06995781

Evaluation of the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)

A study testing Experimental Intervention and Active Comparator Intervention in people with Refractive Error - Myopia Simple, run by Pegavision Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to learn if PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3) are safe and effective for vision correction in adults. It will also assess the comfort and overall experience of wearing these lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error - Myopia Simple
What is being tested?: Experimental Intervention and Active Comparator Intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: No sites listed yet
Study dates: 21 Jan 2025to 14 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must be at least 18 years of age on the date the ICF is signed and have the capacity to provide voluntary informed consent.
Subjects must be myopic and require lens correction from -1.00 to -8.00 Diopter (D) with ≤ 1.00 D astigmatism in each eye.
Subjects must be correctable through spherocylindrical refraction to Log Mar 0.1 or better in each eye.
Subjects must be adapted to soft contact lens wearers.
Subjects agree to follow the protocol and are willing to wear their study lenses for at least 8 hours per day at least 5 days per week on a daily disposable wear basis during the study.

Who cannot join

Subjects who exhibit allergies to contact lens materials, contact lens packaging solutions, or possess a history of allergies that contraindicate conventional contact lens wear.
Subjects live in environments unsuitable for soft lens wear (like areas with dust, chemicals, aerosols).
Subjects presenting with active ocular conditions. These conditions include, but are not limited to, uveitis, corneal hypoesthesia, corneal epithelial defect, severe dry eye, lacrimal duct defect, glaucoma, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.
Use of systemic medications that are known to interfere with contact lenses wear at the investigator's discretion.
Currently pregnant (to the best of the Subject's knowledge), lactating or planning a pregnancy within the next 3 months
Any active participation in any contact lens or lens care product clinical trial within fourteen days prior to this study.

Show all 13Show fewer

The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
Subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
Subject has a history of papillary conjunctivitis that has interfered with contact lens wear.
Subject has a history of herpetic keratitis retinal detachment or irregular cornea.
Subject has a history of recurrent eye or eyelid infections, adverse effects associated with your contact lens wear, intolerance or an unusual response to your contact lens wear.
The Subject currently has pathological dry eye (tear break-up time ≤ 5 seconds).
Subjects who have undergone or plan to undergo corneal or intraocular surgery during the study period.

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel, Controlled Study Assessing the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)

Do PEGAVISION G3 lenses provide vision correction comparable to CooperVision Clariti 1 day contact lenses? What medical problems or discomfort do participants experience when using PEGAVISION G3 lenses?

Researchers will compare PEGAVISION G3 lenses to CooperVision Clariti 1 day contact lenses to determine if they are a safe and effective option for daily vision correction.

Read the detailed description

The clinical trial is designed to evaluate the safety and efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3) in adults who require vision correction for myopia or hyperopia. This is a multicenter, randomized, double-blind, parallel, controlled study comparing the investigational lenses to CooperVision Clariti 1 day contact lenses.

Participants will be randomly assigned to either the PEGAVISION G3 lens group or the control group using Clariti 1 day lenses in a 2:1 ratio. They will wear the assigned lenses daily for at least eight hours per day, five days per week, over a three-month period. Throughout the study, participants will undergo regular assessments to measure visual acuity, lens fit, comfort, and overall visual experience.

The study aims to determine whether PEGAVISION G3 lenses provide non-inferior vision correction compared to the control lenses, while also evaluating safety through ocular health assessments and adverse event monitoring. Slit-lamp biomicroscopy and other eye health evaluations will be performed to assess any corneal abnormalities, irritation, or other complications.

In addition, participants will complete questionnaires on lens comfort and visual quality, and compliance will be monitored through lens usage logs. The study results will help determine whether PEGAVISION G3 lenses are a viable and safe option for daily vision correction.

Conditions: Refractive Error - Myopia Simple
Being tested: Experimental Intervention, Active Comparator Intervention
Keywords: refractive error, myopia simple, contact lenses
Medical subject headings: Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental InterventionDevice
Name: PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses Type: Medical Device (Investigational) Description: Participants in this arm will wear PEGAVISION G3 daily disposable silicone hydrogel soft contact lenses for three months to evaluate their safety, efficacy, and comfort compared to the control group.
Active Comparator InterventionDevice
Name: CooperVision Clariti 1 day Soft Contact Lenses Type: Medical Device (Approved Comparator) Description: Participants in this arm will wear Clariti 1 day daily disposable soft contact lenses, serving as the control group for comparison with PEGAVISION G3 lenses.
Both interventions involve daily wear for at least 8 hours per day, 5 days per week, over a 3-month period, with periodic assessments of visual acuity, safety, and comfort.

Study groups in NCT06995781
Study group	Role	What they receive
Experimental arm	Experimental	The arms in this clinical trial are classified as: Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group). Receives: Device: Experimental Intervention
Active Comparator Arm	Active comparator	Participants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group). Receives: Device: Active Comparator Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
Distance visual acuity (VA), corrected by contact lenses in both eyes, will be measured using the LogMAR chart. The mean LogMAR score at each time point (Day 1, 1 week, 1 month, 2 months, and 3 months) will be used to assess visual performance over time.
Unit of Measure: LogMAR (logarithm of the minimum angle of resolution)
Measured: Day 1, 1 week (±2 days), 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days)

Secondary outcomes (3)

Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
Incidence of corneal abnormalities, including corneal edema, epithelial microcysts, corneal staining, limbal/bulbar injection, conjunctival abnormalities, and corneal neovascularization/infiltrates, as assessed using slit-lamp examination and graded with the Efron Grading Scale.
Outcome is longitudinal tracking of the same measure (not multiple distinct outcomes
Measured: up to 12 weeks
Lens Fit and Surface Condition (Coverage)
Lens Fit and Surface Condition Measure: Lens centration, movement, and deposits assessed via slit-lamp biomicroscopy.
Time Frame: Assessed at all study visits. Purpose: To compare the on-eye performance and stability of PEGAVISION G3 lenses with control lenses.
Measured: up to 12 weeks
Adverse Events Monitoring
Adverse Events Monitoring Measure: Number and type of adverse events related to contact lens use. Time Frame: Throughout the entire study duration. Purpose: To monitor potential complications and evaluate the safety profile of PEGAVISION G3 lenses.
Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jan 202514 Aug 2025

First posted29 May 2025
Study start21 Jan 2025
Primary completion14 Aug 2025
Study completion14 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Refractive Error - Myopia SimpleStudies 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This clinical trial is a multicenter, randomized, double-blind, parallel, controlled study designed to assess the safety and efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3). The study will enroll 69 subjects (138 eyes), accounting for an anticipated 15% dropout rate. The trial will be conducted at five investigational sites (five in the United States), with enrollment distributed across sites to ensure that no single location contributes more than 25% of the total subjects. It is conducted under double-blind conditions. A pre-established randomization protocol will be followed, and all study lenses will be labeled as Lens A or Lens B, with assignments recorded in a randomization log that is accessible only to authorized study personnel .
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06995781
Sponsor's protocol ID: G3-01
Status last verified: May 2025
First submitted: 8 Apr 2025
Last updated: 20 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided: Undecided

Publications

Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Available from http://www.ncbi.nlm.nih.gov/books/NBK201/
PubMed 21250045
Premarket Notficiation 〔510 (k)〕Guidance Dacument for Class II Daily Wear Contact Lenses (1994)
McAlinden C, Skiadaresi E, Gatinel D, Cabot F, Huang J, Pesudovs K. The Quality of Vision questionnaire: subscale interchangeability. Optom Vis Sci. 2013 Aug;90(8):760-4. doi: 10.1097/OPX.0b013e3182993856.
PubMed 23792364
Okumura Y, Inomata T, Iwata N, Sung J, Fujimoto K, Fujio K, Midorikawa-Inomata A, Miura M, Akasaki Y, Murakami A. A Review of Dry Eye Questionnaires: Measuring Patient-Reported Outcomes and Health-Related Quality of Life. Diagnostics (Basel). 2020 Aug 5;10(8):559. doi: 10.3390/diagnostics10080559.
PubMed 32764273
Berntsen DA, Hickson-Curran SB, Jones LW, Mathew JH, Maldonado-Codina C, Morgan PB, Schulze MM, Nichols JJ; Performance of Contact Lens Solutions Study Group. Subjective Comfort and Physiology with Modern Contact Lens Care Products. Optom Vis Sci. 2016 Aug;93(8):809-19. doi: 10.1097/OPX.0000000000000901.
PubMed 27309523
Holladay JT. Visual acuity measurements. J Cataract Refract Surg. 2004 Feb;30(2):287-90. doi: 10.1016/j.jcrs.2004.01.014. No abstract available.
PubMed 15030802
Long B, McNally J. The clinical performance of a silicone hydrogel lens for daily wear in an Asian population. Eye Contact Lens. 2006 Mar;32(2):65-71. doi: 10.1097/01.icl.0000175915.01688.ba.
PubMed 16538125
Doughty MJ, Aakre BM, Ystenaes AE, Svarverud E. Short-term adaptation of the human corneal endothelium to continuous wear of silicone hydrogel (lotrafilcon A) contact lenses after daily hydrogel lens wear. Optom Vis Sci. 2005 Jun;82(6):473-80. doi: 10.1097/01.opx.0000168559.84788.0b.
PubMed 15976584
Sivak, D.F.K.D.I.J.A., Higher oxygen levels mean a healthier cornea with fewer contact lens-related complications. Contact Lens Spectrum, 2006.
Tran NP, Ting CC, Lin CH, Yang MC. A Novel Approach to Increase the Oxygen Permeability of Soft Contact Lenses by Incorporating Silica Sol. Polymers (Basel). 2020 Sep 14;12(9):2087. doi: 10.3390/polym12092087.
PubMed 32937918
LÍM, O.W.D., Hydrophilic Gels for Biological Use. Nature, 1960. 185: p. 117-118.
Mandell, R.B., Contact lens practice. 4th ed. 1988, Springfield, Ill., U.S.A.: Thomas. xiii, 1025 p.
Phillips, A.J. and L. Speedwell, Contact lenses. 5th ed. 2007, Edinburgh ; New York: Butterworth-Heinemann. xvi, 665 p.

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Parallel, Controlled Study Assessing the Safety and Efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3)
ClinicalTrials.gov ID: NCT06995781
Acronym / sponsor ID: G3-01
Conditions: Refractive Error - Myopia Simple
Keywords: refractive error, myopia simple, contact lenses
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Pegavision CorporationIndustry (pharma, biotech, devices)
Study start: 21 Jan 2025 (actual)
Primary completion: 14 Aug 2025 (actual)
Study completion: 14 Aug 2025 (actual)
First posted: 29 May 2025 (actual)
Results: Posted 20 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Researchers will compare PEGAVISION G3 lenses to CooperVision Clariti 1 day contact lenses to determine if they are a safe and effective option for daily vision correction.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This clinical trial is a multicenter, randomized, double-blind, parallel, controlled study designed to assess the safety and efficacy of PEGAVISION Silicone Hydrogel Daily Disposable Soft Contact Lenses (G3). The study will enroll 69 subjects (138 eyes), accounting for an anticipated 15% dropout rate. The trial will be conducted at five investigational sites (five in the United States), with enrollment distributed across sites to ensure that no single location contributes more than 25% of the total subjects. It is conducted under double-blind conditions. A pre-established randomization protocol will be followed, and all study lenses will be labeled as Lens A or Lens B, with assignments recorded in a randomization log that is accessible only to authorized study personnel .

Arm	Type	Receives
Experimental arm	Experimental	Device: Experimental InterventionThe arms in this clinical trial are classified as: Experimental Arm - Participants receive the PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses (Test Group).
Active Comparator Arm	Active comparator	Device: Active Comparator InterventionParticipants receive the CooperVision Clariti 1 day Soft Contact Lenses (Control Group).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects must be at least 18 years of age on the date the ICF is signed and have the capacity to provide voluntary informed consent.
Subjects must be myopic and require lens correction from -1.00 to -8.00 Diopter (D) with ≤ 1.00 D astigmatism in each eye.
Subjects must be correctable through spherocylindrical refraction to Log Mar 0.1 or better in each eye.
Subjects must be adapted to soft contact lens wearers.
Subjects agree to follow the protocol and are willing to wear their study lenses for at least 8 hours per day at least 5 days per week on a daily disposable wear basis during the study.

Key exclusion criteria (13 listed)

Subjects who exhibit allergies to contact lens materials, contact lens packaging solutions, or possess a history of allergies that contraindicate conventional contact lens wear.
Subjects live in environments unsuitable for soft lens wear (like areas with dust, chemicals, aerosols).
Subjects presenting with active ocular conditions. These conditions include, but are not limited to, uveitis, corneal hypoesthesia, corneal epithelial defect, severe dry eye, lacrimal duct defect, glaucoma, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.
Use of systemic medications that are known to interfere with contact lenses wear at the investigator's discretion.
Currently pregnant (to the best of the Subject's knowledge), lactating or planning a pregnancy within the next 3 months

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
Experimental InterventionName: PEGAVISION G3 Silicone Hydrogel Daily Disposable Soft Contact Lenses Type: Medical Device (Investigational) Description: Participants in this arm will wear PEGAVISION G3 daily disposable silicone hydrogel soft contact lenses for three months to evaluate their safety, efficacy, and comfort compared to the control group.	Device	Experimental arm
Active Comparator InterventionName: CooperVision Clariti 1 day Soft Contact Lenses Type: Medical Device (Approved Comparator) Description: Participants in this arm will wear Clariti 1 day daily disposable soft contact lenses, serving as the control group for comparison with PEGAVISION G3 lenses. Both interventions involve daily wear for at least 8 hours per day, 5 days per week, over a 3-month period, with periodic assessments of visual acuity, safety, and comfort.	Device	Active Comparator Arm

Primary outcome

Change in Distance Visual Acuity (VA) Corrected by Contact Lenses
Time frame: Day 1, 1 week (±2 days), 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days)
Distance visual acuity (VA), corrected by contact lenses in both eyes, will be measured using the LogMAR chart. The mean LogMAR score at each time point (Day 1, 1 week, 1 month, 2 months, and 3 months) will be used to assess visual performance over time. Unit of Measure: LogMAR (logarithm of the minimum angle of resolution)

3 secondary outcomes

Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale
Time frame: up to 12 weeks
Lens Fit and Surface Condition (Coverage)
Time frame: up to 12 weeks
Adverse Events Monitoring
Time frame: up to 12 weeks

Results and safety

Results posted to the registry on 20 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Arm	46	46
Active Comparator Arm	23	23

Primary outcome: Change in Distance Visual Acuity (VA) Corrected by Contact Lenses

Time frame: Day 1, 1 week (±2 days), 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days). Mean (Standard Deviation). Unit: logMAR

Measure	Experimental Arm n = 46	Active Comparator Arm n = 23
Baseline	-0.08 (0.061)	-0.08 (0.050)
1-week	-0.08 (0.059)	-0.09 (0.059)
1-month	-0.09 (0.065)	-0.08 (0.057)
2-month	-0.09 (0.070)	-0.10 (0.066)
3-month	-0.10 (0.059)	-0.12 (0.075)
Average VA across all visits	-0.09 (0.057)	-0.10 (0.057)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, up to 3-month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Arm	0 of 46 (0%)	2 of 46 (4.3%)	0 of 46
Active Comparator Arm	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23

Limitations and caveats (from the sponsor): All-cause mortality was assessed during the study period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21250045Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Available from http://www.ncbi.nlm.nih.gov/books/NBK201/
BackgroundPremarket Notficiation 〔510 (k)〕Guidance Dacument for Class II Daily Wear Contact Lenses (1994)
Background: PubMed 23792364McAlinden C, Skiadaresi E, Gatinel D, Cabot F, Huang J, Pesudovs K. The Quality of Vision questionnaire: subscale interchangeability. Optom Vis Sci. 2013 Aug;90(8):760-4. doi: 10.1097/OPX.0b013e3182993856.
Background: PubMed 32764273Okumura Y, Inomata T, Iwata N, Sung J, Fujimoto K, Fujio K, Midorikawa-Inomata A, Miura M, Akasaki Y, Murakami A. A Review of Dry Eye Questionnaires: Measuring Patient-Reported Outcomes and Health-Related Quality of Life. Diagnostics (Basel). 2020 Aug 5;10(8):559. doi: 10.3390/diagnostics10080559.
Background: PubMed 27309523Berntsen DA, Hickson-Curran SB, Jones LW, Mathew JH, Maldonado-Codina C, Morgan PB, Schulze MM, Nichols JJ; Performance of Contact Lens Solutions Study Group. Subjective Comfort and Physiology with Modern Contact Lens Care Products. Optom Vis Sci. 2016 Aug;93(8):809-19. doi: 10.1097/OPX.0000000000000901.
Background: PubMed 15030802Holladay JT. Visual acuity measurements. J Cataract Refract Surg. 2004 Feb;30(2):287-90. doi: 10.1016/j.jcrs.2004.01.014. No abstract available.
Background: PubMed 16538125Long B, McNally J. The clinical performance of a silicone hydrogel lens for daily wear in an Asian population. Eye Contact Lens. 2006 Mar;32(2):65-71. doi: 10.1097/01.icl.0000175915.01688.ba.
Background: PubMed 15976584Doughty MJ, Aakre BM, Ystenaes AE, Svarverud E. Short-term adaptation of the human corneal endothelium to continuous wear of silicone hydrogel (lotrafilcon A) contact lenses after daily hydrogel lens wear. Optom Vis Sci. 2005 Jun;82(6):473-80. doi: 10.1097/01.opx.0000168559.84788.0b.
BackgroundSivak, D.F.K.D.I.J.A., Higher oxygen levels mean a healthier cornea with fewer contact lens-related complications. Contact Lens Spectrum, 2006.
Background: PubMed 32937918Tran NP, Ting CC, Lin CH, Yang MC. A Novel Approach to Increase the Oxygen Permeability of Soft Contact Lenses by Incorporating Silica Sol. Polymers (Basel). 2020 Sep 14;12(9):2087. doi: 10.3390/polym12092087.
BackgroundLÍM, O.W.D., Hydrophilic Gels for Biological Use. Nature, 1960. 185: p. 117-118.
BackgroundMandell, R.B., Contact lens practice. 4th ed. 1988, Springfield, Ill., U.S.A.: Thomas. xiii, 1025 p.
Individual participant dataSharing planned: Undecided. Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Intervention and Active Comparator Intervention in people with Refractive Error - Myopia Simple, run by Pegavision Corporation.

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 13 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Distance Visual Acuity (VA) Corrected by Contact Lenses (time frame: Day 1, 1 week (±2 days), 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06995781, which also lists 13 linked publications.

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 20 Aug 2026.