Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions

NCT ID: NCT01847105

Last Updated: 2013-05-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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

Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).

Detailed Description

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

According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.

The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.

Conditions

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

Contact Lens Solution Toxicity

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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

RevitaLens

AMO's RevitaLens contact lens solution

Group Type EXPERIMENTAL

RevitaLens

Intervention Type OTHER

Multi-purpose disinfecting solution

OptiFree PureMoist

Intervention Type OTHER

Multi-purpose disinfecting solution

Interventions

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

RevitaLens

Multi-purpose disinfecting solution

Intervention Type OTHER

OptiFree PureMoist

Multi-purpose disinfecting solution

Intervention Type OTHER

Other Intervention Names

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

AMO's RevitaLens Alcon's OptiFree PureMoist MPS

Eligibility Criteria

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

Inclusion Criteria

1. Between the ages of 18 and over inclusive.
2. Males or females
3. Patient is in generally good \& stable overall health.
4. Patient likely to comply with study guidelines \& study visits.
5. Informed consent signed.
6. Are willing/able to return for all required study visits.
7. Are willing/able to follow instructions from the study investigator and his/her staff.
8. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria

1. Corneal refractive surgery within 6 months of this study.
2. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
3. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Medical Optics

INDUSTRY

Sponsor Role collaborator

Hom, Milton M., OD, FAAO

INDIV

Sponsor Role lead

Responsible Party

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

Milton M. Hom, OD, FAAO.

Optometrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Milton M Hom, OD FAAO

Role: PRINCIPAL_INVESTIGATOR

Locations

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

Milton M. Hom, OD, FAAO

Azusa, California, United States

Site Status

Kirk L. Smick, OD, FAAO.

Morrow, Georgia, United States

Site Status

Ian Ben Gaddie, OD, FAAO.

Louisville, Kentucky, United States

Site Status

Countries

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

United States

Other Identifiers

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

12-GHS Comfort Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.