NCT01847105

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

April 24, 2013

Last Update Submit

May 25, 2013

Conditions

Contact Lens Solution Toxicity

Outcome Measures

Primary Outcomes (1)

  • Self-reported comfort scores with contact lens care systems

    Comfort measured by questionnaires covering positive and negative attributes of contact lens wear

    14 days

Study Arms (1)

RevitaLens

EXPERIMENTAL

AMO's RevitaLens contact lens solution

Other: RevitaLensOther: OptiFree PureMoist

Interventions

RevitaLensOTHER

Multi-purpose disinfecting solution

Also known as: AMO's RevitaLens
RevitaLens
OptiFree PureMoistOTHER

Multi-purpose disinfecting solution

Also known as: Alcon's OptiFree PureMoist MPS
RevitaLens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Milton M. Hom, OD, FAAO

Azusa, California, 91702, United States

Location

Kirk L. Smick, OD, FAAO.

Morrow, Georgia, 30260, United States

Location

Ian Ben Gaddie, OD, FAAO.

Louisville, Kentucky, 40222, United States

Location

Study Officials

  • Milton M Hom, OD FAAO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Optometrist

Study Record Dates

First Submitted

April 24, 2013

First Posted

May 6, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

US(3)