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
  Purpose

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 Intervention Phase
Endogenous Anterior Uveitis
Drug: Difluprednate 0.05% ophthalmic emulsion
Drug: Prednisolone acetate 1.0% ophthalmic suspension
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 111
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201798

Locations
United States, Texas
Contact Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided by Alcon Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01201798     History of Changes
Other Study ID Numbers: C-10-034
Study First Received: September 13, 2010
Results First Received: August 31, 2012
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Iris Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Fluprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Difluprednate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 18, 2014