NCT00817557

Brief Summary

Study of the effects of Loteprednol on CL dryness

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
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 6, 2009

Status Verified

January 1, 2009

Enrollment Period

5 months

First QC Date

January 2, 2009

Last Update Submit

January 5, 2009

Conditions

Contact Lenses Dryness

Keywords

Contact lensesLoteprednolEffect on CL dryness

Outcome Measures

Primary Outcomes (1)

  • Wearing time

    28 days

Secondary Outcomes (1)

  • OSDI

    28 days

Study Arms (2)

Loteprednol

ACTIVE COMPARATOR

Loteprednol BID

Drug: Loteprednol

Rewetter

PLACEBO COMPARATOR

Rewetter BID

Other: Rewetter

Interventions

LoteprednolDRUG

Anti-inflammatory

Loteprednol
RewetterOTHER
Rewetter

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
  • Any race or ethnic background
  • CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.
  • Patient is in generally good \& stable overall health.
  • Patient likely to comply with study guidelines \& study visits.
  • Informed consent signed.
  • OSDI score 18 or higher while wearing lenses
  • Unsatisfactory wearing time with contact lenses

You may not qualify if:

  • Corneal refractive surgery within 6 months of this study.
  • Contact lens use on day of examination.
  • Corneal ectasia.
  • Current use of Restasis
  • Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
  • Pregnant or lactating women.
  • 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 (1)

Milton M. Hom, OD, FAAO.

Azusa, California, 91702, United States

Location

MeSH Terms

Interventions

Loteprednol Etabonate

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Milton M Hom, OD FAAO

    Private Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

January 2, 2009

First Posted

January 6, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

January 6, 2009

Record last verified: 2009-01

Locations

US(1)