Refractive Error - Myopia Simple
Conditions
Keywords
refractive error, myopia simple, contact lenses
Brief 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. The main questions it aims to answer are: 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.
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.
Interventions
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.
DEVICEActive Comparator Intervention
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.
Sponsors
Pegavision Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study lenses will be labeled as Lens A or Lens B to prevent identification of the test and control lenses. A randomization log will be maintained, containing lens assignments, but access will be restricted to authorized personnel only. The investigators, study coordinators, and participants will remain blinded to the assigned lenses throughout the study. If unmasking is necessary due to safety concerns, a predefined decoding procedure will be followed and documented in the investigator's study binder.
Intervention 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 .
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Subjects must be myopic and require lens correction from -1.00 to -8.00 Diopter (D) with ≤ 1.00 D astigmatism in each eye. 3. Subjects must be correctable through spherocylindrical refraction to Log Mar 0.1 or better in each eye. 4. Subjects must be adapted to soft contact lens wearers. 5. 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.
Exclusion criteria
1. Subjects who exhibit allergies to contact lens materials, contact lens packaging solutions, or possess a history of allergies that contraindicate conventional contact lens wear. 2. Subjects live in environments unsuitable for soft lens wear (like areas with dust, chemicals, aerosols). 3. 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. 4. Use of systemic medications that are known to interfere with contact lenses wear at the investigator's discretion. 5. Currently pregnant (to the best of the Subject's knowledge), lactating or planning a pregnancy within the next 3 months 6. Any active participation in any contact lens or lens care product clinical trial within fourteen days prior to this study. 7. 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. 8. Subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections. 9. Subject has a history of papillary conjunctivitis that has interfered with contact lens wear. 10. Subject has a history of herpetic keratitis retinal detachment or irregular cornea. 11. 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. 12. The Subject currently has pathological dry eye (tear break-up time ≤ 5 seconds). 13. Subjects who have undergone or plan to undergo corneal or intraocular surgery during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Distance Visual Acuity (VA) Corrected by Contact Lenses | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Corneal Abnormalities Above Grade 2 on the Efron Grading Scale | up to 12 weeks | 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 |
| Lens Fit and Surface Condition (Coverage) | up to 12 weeks | 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. |
| Adverse Events Monitoring | up to 12 weeks | 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. |
Participant flow
Recruitment details
The study enrolled and randomly assigned 69 subjects, including a 15% dropout rate. The study was conducted at 5 investigational sites with ≤ 25% differences in enrollment numbers between sites. Upon registration at each study site, subjects sequentially assigned a random identification number and allocated to either the test or control groups in a 2:1 ratio.
Pre-assignment details
Lens distribution complied with a pre-established randomization protocol, which was communicated to authorized personnel at each research site. To mitigate bias, the study was conducted under double-blind conditions. Prior to the initiation of contact lens wear, subjects received comprehensive instructions on the contact lens fitting process.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 31.10 years STANDARD_DEVIATION 7.928 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 11 Participants |
| Tear Breakup Time Test test Left eye(OS) | 8.61 seconds STANDARD_DEVIATION 1.842 |
| Tear Breakup Time Test test Right eye(OD） | 8.76 seconds STANDARD_DEVIATION 1.779 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 23 |
| other Total, other adverse events | 2 / 46 | 1 / 23 |
| serious Total, serious adverse events | 0 / 46 | 0 / 23 |
Outcome results
None listed