Clinical Evaluation of Two Silicone Hydrogel Contact Lenses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-27

Study Completion Date

2022-04-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

NCT05333965

Myopia

COMPLETED NA

Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses

NCT02131402

Myopia

COMPLETED NA

Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

NCT00810511

Myopia

COMPLETED NA

Performance of Toric Silicone Hydrogel Contact Lenses

NCT05097144

Astigmatism Myopia

COMPLETED NA

Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

NCT05166902

Ametropia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lens A, Then Lens B

Participants will wear Lens A for six hours and then cross over to wear Lens B for six hours.

Group Type EXPERIMENTAL

Lens A (comfilcon A lens)

Intervention Type DEVICE

6 hours

Lens B (lehfilcon A lens)

Intervention Type DEVICE

6 hours

Lens B, Then Lens A

Participants will wear Lens B for six hours and then cross over to wear Lens A for six hours.

Group Type EXPERIMENTAL

Lens A (comfilcon A lens)

Intervention Type DEVICE

6 hours

Lens B (lehfilcon A lens)

Intervention Type DEVICE

6 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lens A (comfilcon A lens)

6 hours

Intervention Type DEVICE

Lens B (lehfilcon A lens)

6 hours

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. They are aged between 18 and 40 years.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They have successfully worn contact lenses within six months of starting the study.
5. They can be satisfactorily fitted with the study contact lenses.
6. They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.
7. They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.
8. They own and habitually wear single vision spectacles.
9. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.
10. They agree not to participate in other clinical research while enrolled on this study.

Exclusion Criteria

1. They have an ocular disorder which would normally contraindicate contact lens wear.
2. They have a systemic disorder which would normally contraindicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.
9. They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
10. They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes