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Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01201798
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : November 15, 2012
Last Update Posted : November 15, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.

Condition or disease Intervention/treatment Phase
Endogenous Anterior Uveitis Drug: Difluprednate 0.05% ophthalmic emulsion Drug: Prednisolone acetate 1.0% ophthalmic suspension Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis
Study Start Date : October 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Durezol
Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
 Drug: Difluprednate 0.05% ophthalmic emulsion
1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
Other Name: Durezol
Active Comparator: Pred Forte
Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
 Drug: Prednisolone acetate 1.0% ophthalmic suspension
1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
Other Name: Pred Forte


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 [ Time Frame: Baseline (Day 0), Day 14 ]
    Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.


Secondary Outcome Measures :
  1. Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14 [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42 ]
    Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.

  2. Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe.

  3. Proportion of Subjects With Anterior Chamber Cell Grade of 0 [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects.

  4. Proportion of Subjects With Anterior Chamber Cell Count of 0 [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects.

  5. Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0 [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects.

  6. Proportion of Subjects With Anterior Chamber Cell Grade ≤1 [ Time Frame: Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects.

  7. Proportion of Subjects Who Discontinued Due to Lack of Efficacy [ Time Frame: Time to Event ]
    Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects.

  8. Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores.

  9. Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits [ Time Frame: Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 ]
    The following signs were each graded on a 0 - 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23.


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of endogenous anterior uveitis in at least 1 eye.
  • The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye.
  • Age 2 years or older on day of consent.
  • Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study.
  • Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
  • Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.
  • History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
  • History of steroid-induced elevation of intraocular pressure.
  • Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye.
  • History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.
  • Corneal abrasion or ulceration in either eye.
  • Pregnancy or lactation.
  • Other protocol-defined exclusion criteria may apply.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201798


Locations
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United States, Texas
Contact Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01201798    
Other Study ID Numbers: C-10-034
First Posted: September 15, 2010    Key Record Dates
Results First Posted: November 15, 2012
Last Update Posted: November 15, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Panuveitis
Iris Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
 Difluprednate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents