One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-08

Study Completion Date

2015-05-23

Brief Summary

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

Comparison of different contact lens materials.

Related Clinical Trials

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

Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses

NCT02249689

Ametropia

COMPLETED NA

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

NCT05166902

Ametropia

COMPLETED NA

Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens

NCT01151371

Myopia

COMPLETED NA

Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear

NCT00346593

Myopia

COMPLETED NA

Clinical Evaluation of Two Silicone Hydrogel Contact Lenses

NCT05313412

Myopia

COMPLETED NA

Detailed Description

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

This is a 1-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.

Conditions

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

Ametropia

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Definitive 65 HPT

The Test product were the Definitive 65 (Filcon V4) lenses with Hydra PEG surface coating. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.

Group Type EXPERIMENTAL

Definitive 65 HPT contact lenses

Intervention Type DEVICE

Definitive 65

The Control product was the commercially available Definitive 65 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.

Group Type ACTIVE_COMPARATOR

Definitive 65 contact lenses

Intervention Type DEVICE

Interventions

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

Definitive 65 HPT contact lenses

Intervention Type DEVICE

Definitive 65 contact lenses

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Filcon V4 (HPT) Filcon V4

Eligibility Criteria

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

Inclusion Criteria

* willing and able to sign informed consent form
* ages 18 years or older
* Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
* Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
* Astigmatic power ≤0.75 D

Exclusion Criteria

* Eye injury or surgery within 3 months immediately prior to enrolment for this trial
* Pre-existing ocular irritation that would preclude contact lens fitting
* Currently enrolled in an ophthalmic clinical trial
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
* Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
* Current extended-wear users (sleep-in overnight)
* Current monovision lens wearers
* Pregnant women and nursing mothers
* Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes