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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01201798
First received: September 13, 2010
Last updated: October 15, 2012
Last verified: October 2012

September 13, 2010
October 15, 2012
October 2010
August 2011   (final data collection date for primary outcome measure)
Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 [ Time Frame: Baseline (Day 0), Day 14 ] [ Designated as safety issue: No ]
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.
Change from baseline in anterior chamber cell grade [ Time Frame: Change from baseline at Day 14 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01201798 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Proportion of Subjects Who Discontinued Due to Lack of Efficacy [ Time Frame: Time to Event ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Anterior chamber flare [ Time Frame: Change from baseline at Day 14 ] [ Designated as safety issue: No ]
  • Total sign score [ Time Frame: Change from baseline at Day 14 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Endogenous Anterior Uveitis
  • 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
  • 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
  • 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
    Intervention: Drug: Difluprednate 0.05% ophthalmic emulsion
  • 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
    Intervention: Drug: Prednisolone acetate 1.0% ophthalmic suspension
Sheppard JD, Toyos MM, Kempen JH, Kaur P, Foster CS. Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):2993-3002. doi: 10.1167/iovs.13-12660.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01201798
C-10-034
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP