A Comparison of 12 Month Daily Wear of Two Novel O2 Permeable Silicone Hydrogel CLs (HOP/SiH) and A Control, Standard O2 Lens

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

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-12-31

Brief Summary

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

The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses by studying its effects on human eyes. Usual and customary care will be given in the form of eyeglasses and/or contact lenses.

Detailed Description

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

The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses on bacterial binding to corneal cells and central epithelial thickness. Usual and customary care will be given in the form of eyeglasses and contact lenses. To compare long-term Daily wear vs. immediate Overnight wear (Extended wear) of a new hyper-oxygen permeable silicone hydrogel contact lens on binding of Pseudomonas Aeruginosa to exfoliated human surface corneal cells collected from the eyes of human patients and on central corneal thickness, as follows: 1) a hyper Dk/t lens for 12 months of daily wear, 2) a hyper Dk/t lens for 12 months of de novo 6 night extended wear, and 3) a hyper Dk/t lens for 12 months of de novo 30 night extended wear.

Conditions

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

Contact Lenses, Extended-Wear

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Comparison of Daily wear versus Extended wear in bacterial binding and corneal epithelial thickness

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

Blinding Strategy

NONE

Interventions

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

Silicone Hydrogel Soft Contact Lenses

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

Inclusion Criteria: The age requirement for this study is between 18-38 years old. The subject has to have nearsightedness in between -1.00D and -6.00D with regular astigmatism of an amount in both eyes that will not necessitate the need for toric lenses. No prior history of any lens wear within one month of entry into the contact lens phase of the study. Visual acuity of 20/30 or better during test lens wear. Normal anatomy and physiology of the eye. No eye cosmetic use on the day of study visits. Normal appearance of the cornea with slit lamp examination, stable tear film and sufficient tear production. Intraocular pressure less than or equal to 21 mmHg by Goldmann applanation. Absence of any intraocular inflammation. Normal appearance of optic nerve, macula and peripheral retina by direct fundus examination.

Exclusion Criteria: Patients with chronic ocular conditions are excluded from the study (i.e. dry eye, recurrent corneal epithelial erosion). History of allergic eye disease either seasonal or associated with previous contact lens wear. Use of any topically applied ocular medication or systemic medication specifically including but not limited to, antihistamines, aspirin-related drugs, or psychoactive or anti-depressant medication. Oral contraceptives are allowed. Currently suspected or actual pregnancy. Study terminates if pregnancy occurs. Patients will not be enrolled if they are currently in another ophthalmic research project.

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

UTSW Medical Center at Dallas

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harrison D Cavanagh, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas Southwestern Medical Center At Dallas

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Robertson DM, Petroll WM, Cavanagh HD. The effect of nonpreserved care solutions on 12 months of daily and extended silicone hydrogel contact lens wear. Invest Ophthalmol Vis Sci. 2008 Jan;49(1):7-15. doi: 10.1167/iovs.07-0940.

Reference Type DERIVED

PMID: 18172068 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0202-112

Identifier Type: -

Identifier Source: org_study_id