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Dry EyePhase 2NCT00560638

Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

A Phase 2 study testing loteprednol etabonate ophthalmic suspension, 0.5% in people with Dry Eye, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a single-center, randomized, double-masked, placebo-controlled, parallel-group, 4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo (vehicle of loteprednol etabonate ophthalmic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye
What is being tested?
loteprednol etabonate ophthalmic suspension, 0.5%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
119 participants
Where
1 siteUnited States
Study dates
Nov 2005to Feb 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • at least 18 years of age or older
  • able and willing to follow instructions, including participation in study assessments and able be present for the required study visits for the duration of the study
  • If female and of childbearing potential, were not pregnant, nursing, or planning a pregnancy. Women of childbearing potential were required to have a negative urine pregnancy test at the pre-screen visit and had to agree to use an acceptable method of mechanical or hormonal contraceptive for the duration of the study
  • a diagnosis of dry eye
  • a history of intermittent or regular artificial tear use within the past 3 months
  • best corrected visual acuity (BCVA) of +0.7 or better assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in one or both eyes
  • a fluorescein staining score of ≥ 1+ in at least one region in at least one eye at Visit 1 and before CAE exposure at Visits 2 and 3 OR a fluorescein staining score of ≥ 1+ in at least one region in at least one eye at Visit 1 and before CAE exposure at Visits 2 and 3 with a conjunctival redness score of ≥ 1.5+ at Visit 1 and before CAE exposure at Visits 2 and 3 in at least one eye
  • Demonstrated a response when exposed to the CAE at Visits 2 and 3

Who cannot join

  • clinically significant blepharitis or Meibomian Gland Dysfunction (MGD) or lid margin inflammation, particularly if systemic or topical medications were currently being used to treat any of these diagnoses
  • diagnosed with an on-going ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis), or preauricular lymphadenopathy, particularly if systemic or topical medications were currently being used to treat any of these diagnoses
  • Reported an ocular discomfort score of 4+ in both eyes at time 0 of CAE exposure at Visits 2 or 3
  • Wore contact lenses and refused to remove them for the duration of the study
  • previous laser in situ keratomileusis (LASIK) surgery
  • currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and could not discontinue these medications for the duration of the study
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  • presently taking any medication known to cause ocular drying that had not been a stable dose for at least 30 days
  • currently taking oral antihistamines that could not be discontinued during the study
  • a systemic disease, uncontrolled medical condition that in the opinion of the investigator could interfere with study measurements or subject compliance
  • received another experimental drug or device within 30 days prior to screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ophthalmic Research Associates

    Andover, Massachusetts, 01810

Other trials in United States

About this study

Official title: A Double-Masked, Randomized, Placebo-Controlled Study of Loteprednol Etabonate Ophthalmic Suspension, 0.5% for the Treatment of Dry Eye Used Either TID or QID for a 2 Week Period

This was a single-center, randomized, double-masked, placebo-controlled, parallel-group, 4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose bilaterally either TID or QID according to randomization.

Conditions
Dry Eye
Being tested
loteprednol etabonate ophthalmic suspension, 0.5%, vehicle of loteprednol etabonate
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • loteprednol etabonate ophthalmic suspension, 0.5%Drug

    Also called Lotemax

    TID

  • loteprednol etabonate ophthalmic suspension, 0.5%Drug

    Also called Lotemax

    QID

  • vehicle of loteprednol etabonateDrug

    TID or BID according to the randomization

Study groups in NCT00560638
Study groupRoleWhat they receive
Loteprednol Etabonate TIDExperimentalloteprednol etabonate ophthalmic suspension, 0.5%, TID
Receives: Drug: loteprednol etabonate ophthalmic suspension, 0.5%
Loteprednol Etabonate QIDExperimentalloteprednol etabonate ophthalmic suspension, 0.5%, QID
Receives: Drug: loteprednol etabonate ophthalmic suspension, 0.5%
VehiclePlacebo comparatorvehicle of loteprednol etabonate
Receives: Drug: vehicle of loteprednol etabonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ocular discomfort during CAE exposure

    Measured: during CAE exposure

  2. Corneal and conjunctival staining and conjunctival redness

    Measured: After CAE exposure

Secondary outcomes (3)

  1. Corneal and conjunctival staining and conjunctival redness

    Measured: before CAE exposure

  2. Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI)

    Measured: before after CAE exposure

  3. Ocular discomfort

    Measured: collected in patient diaries

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2007 (estimated)
  2. Study startNov 2005
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00560638
Sponsor's protocol ID
439
Status last verified
Jul 2011
First submitted
19 Nov 2007
Last updated
18 Jul 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing loteprednol etabonate ophthalmic suspension, 0.5% in people with Dry Eye, run by Bausch & Lomb Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular discomfort during CAE exposure (time frame: during CAE exposure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00560638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2011.

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