NCT00817557

UnknownPhase 4

Use of Loteprednol for Contact Lens Intolerance and Dryness

Hom, Milton M., OD, FAAO Source

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Other study identifiers

Sponsor study identifier

05

Study Type

interventional

Estimated enrollment

25

Locations

1 country

Sites

1

Timeline

Study Start

January 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2009

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 2009

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

Study of the effects of Loteprednol on CL dryness

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 25 participants
Study completion date: September 2009
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 2, 2009
Actual (reported)
First Posted
January 6, 2009
Actual (reported)
Primary Completion
June 2009
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2009
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 6, 2009
Status Verified: January 2009
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Hom, Milton M., OD, FAAO
Individuallead
Bausch & Lomb Incorporated
Industrycollaborator

Study Sites (1)

Milton M. Hom, OD, FAAO.

Azusa, California, 91702, United States

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 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2009

Estimated (date passed)

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.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

September 2009

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 6, 2009

Record last verified: 2009-01

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00817557
Data provider: ClinicalTrials.gov
Source updated: 2009-01-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:33 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Loteprednol

Rewetter

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations