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CompletedNCT01028027Updated Feb 28, 2012Results posted

Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

A Phase 3 interventional study of Loteprednol and tobramycin and Tobramycin and dexamethasone in Conjunctivitis, Keratitis and Blepharitis, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in Singapore. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-28.

Sponsored by Bausch & Lomb Incorporated · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
357
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).

02

Conditions studied

  • Conjunctivitis
  • Keratitis
  • Blepharitis

Keywords

  • Blepharokeratoconjunctivitis
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 357 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects must have a clinical diagnosis of BKC in at least one eye
  • Subjects must be willing to discontinue contact lens use for the duration of the study
  • Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion criteria

Exclusion Criteria:

  • Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
  • Subjects who have any uncontrolled systemic disease or debilitating disease.
  • Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
  • Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
  • Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
  • Subjects having ocular surgery (including laser surgery) in either eye within the past three months.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
357 participants (actual)

Study arms

  • Experimental
    Loteprednol and tobramycin

    Loteprednol etabonate and tobramycin ophthalmic suspension

    Drug: Loteprednol and tobramycin

  • Active comparator
    Tobramycin and dexamethasone

    Tobramycin and dexamethasone ophthalmic suspension

    Drug: Tobramycin and dexamethasone

Interventions

  • DrugLoteprednol and tobramycin

    Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.

    Also known as: Zylet

  • DrugTobramycin and dexamethasone

    Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.

    Also known as: Tobradex

06

What researchers measure

Primary outcomes

  1. Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population

    The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).

    Time frame: Baseline, Day 15

Secondary outcomes

  1. Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population

    The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

    Time frame: Baseline, Day 15

  2. Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population

    The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.

    Time frame: Baseline, Day 8

  3. Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population

    The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

    Time frame: Baseline, Day 8

  4. Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population

    The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.

    Time frame: Baseline, Day 3

  5. Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population

    The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.

    Time frame: Baseline, Day 3

07

Results

Posted Sep 15, 2011

Participant flow

This study was conducted at seven sites, by seven Investigators in the People's Republic of China. First participant was enrolled 10/21/2009 and last participant visit was 2/9/2010.

Participant flow — Overall Study
MilestoneLoteprednol and TobramycinTobramycin and Dexamethasone
Started180177
Completed164164
Not completed1613
Withdrew: Lost to follow-up41
Withdrew: Withdrawal by subject53
Withdrew: Adverse event47
Withdrew: Protocol violation31
Withdrew: Lack of efficacy01

Outcome measures

PrimarySigns and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population

The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).

Time frame:
Baseline, Day 15
Reported as:
Mean · Scores on a scale
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
Scores on a scaleLoteprednol and TobramycinTobramycin and Dexamethasone
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population-11.63 ± 4.56-12.41 ± 4.71
SecondarySigns and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population

The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

Time frame:
Baseline, Day 15
Reported as:
Mean · Score on a scale
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
Score on a scaleLoteprednol and TobramycinTobramycin and Dexamethasone
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population-11.64 ± 4.55-11.98 ± 4.95
SecondarySigns and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population

The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.

Time frame:
Baseline, Day 8
Reported as:
Mean · Score on a scale
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
Score on a scaleLoteprednol and TobramycinTobramycin and Dexamethasone
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population-9.20 ± 3.94-10.21 ± 4.23
SecondarySigns and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population

The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population

Time frame:
Baseline, Day 8
Reported as:
Mean · Score on a scale
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
Score on a scaleLoteprednol and TobramycinTobramycin and Dexamethasone
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population-8.91 ± 4.24-9.96 ± 4.27
SecondarySigns and Symptoms Composite Score Change From Baseline to Day 3 - PP Population

The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.

Time frame:
Baseline, Day 3
Reported as:
Mean · Score on a scale
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
Score on a scaleLoteprednol and TobramycinTobramycin and Dexamethasone
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population-5.66 ± 3.46-5.98 ± 3.68
SecondarySigns and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population

The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.

Time frame:
Baseline, Day 3
Reported as:
Mean · Score on a scale
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
Score on a scaleLoteprednol and TobramycinTobramycin and Dexamethasone
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population-5.54 ± 3.48-5.92 ± 3.69

Adverse events

Collected over 14 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Loteprednol and Tobramycin—0/177 (0%)16/177 (9%)
Tobramycin and Dexamethasone—0/177 (0%)36/177 (20.3%)
Most frequent other events
Most frequent other events
EventLoteprednol and TobramycinTobramycin and Dexamethasone
Increased IOPEye disorders16/17736/177

Baseline characteristics

Age Continuous
Age Continuous(Years)Loteprednol and TobramycinTobramycin and DexamethasoneTotal
Mean40.8 ± 13.6341.72 ± 13.5441.26 ± 13.57
Sex: Female, Male
Sex: Female, Male(Participants)Loteprednol and TobramycinTobramycin and DexamethasoneTotal
Female123113236
Male5764121
Region of Enrollment
Region of Enrollment(participants)Loteprednol and TobramycinTobramycin and DexamethasoneTotal
Singapore180177357
08

Study locations

1 site
  • Bausch & Lomb Inc
    Singapore, 556741, Singapore
09

References and documents

Publications

  • Chen M, Gong L, Sun X, Gu Y, He X, Qu J, Wang L, Zhang M, Zhong X. A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis. Curr Med Res Opin. 2012 Mar;28(3):385-94. doi: 10.1185/03007995.2012.659723. Epub 2012 Feb 7. PubMed 22256909 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01028027
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Dec 9, 2009
Start date
Oct 2009
Primary completion
Feb 2010
Completion
Mar 2010
Results posted
Sep 15, 2011
Last update
Feb 28, 2012

Study contacts

Esther Chu
study director · Bausch & Lomb Incorporated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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