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Completed

NCT Number: NCT01201798

Safety and Efficacy of Difluprednate 0.05% for the Treatment of 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.

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Key information

Conditions

Endogenous Anterior Uveitis

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact Alcon Call Center

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Difluprednate 0.05% ophthalmic emulsion

Drug

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 names: Durezol

Prednisolone acetate 1.0% ophthalmic suspension

Drug

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 names: Pred Forte

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2010
Registry last updated
Nov 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.