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Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

Sponsor
ORA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00689078
Collaborator
(none)
36
Enrollment
1
Location
4
Arms
1
Duration (Months)
35.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.

Condition or Disease Intervention/Treatment Phase
  • Drug: Prednisolone Acetate 1%
  • Drug: Prednisolone Acetate 0.12%
  • Drug: Loteprednol Etabonate 0.2%
  • Drug: Placebo
 Phase 4

Detailed Description

Structure:

Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:

  1. Prednisolone Acetate 1% ophthalmic suspension

  2. Prednisolone Acetate 0.12% ophthalmic suspension

  3. Loteprednol Etabonate 0.2% ophthalmic suspension

  4. Tears Naturale® II

Duration:

Approximately four (4) weeks

Controls:

Artificial Tears (Tears Naturale® II)

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pred acetate 1%

Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

Drug: Prednisolone Acetate 1%
One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
Other Names:
  • Pred Forte (Allergan)

    		•
    Active Comparator: Pred acetate .12%

    Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

    Drug: Prednisolone Acetate 0.12%
    One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
    Other Names:
  • Pred Mild (Allergan)

    		•
    Active Comparator: Lot Etab 0.2%

    Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

    Drug: Loteprednol Etabonate 0.2%
    One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
    Other Names:
  • Alrex (Bausch & Lomb)

    		•
    Placebo Comparator: Placebo

    Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

    Drug: Placebo
    One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
    Other Names:
  • Tears Naturale
  • Artificial tears

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ocular Itching at Baseline (Day 0) [3, 5, 7 minutes post-CAC]

      A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

    2. Ocular Itching at Day 6 [3, 5, 7 minutes post-CAC]

      Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

    3. Ocular Itching at Day 7 [3, 5, 7 minutes post-CAC]

      Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

    4. Ocular Itching at Day 27 [3, 5, 7 minutes post-CAC]

      Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

    5. Ocular Itching at Day 28 [3, 5, 7 minutes post-CAC]

      Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

    6. Ocular Redness at Baseline (Day 0) [7, 15, 20 minutes post-CAC]

      A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.

    7. Ocular Redness at Day 6 [7, 15, 20 minutes post-CAC]

      Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.

    8. Ocular Redness at Day 7 [7, 15, 20 minutes post-CAC]

      Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.

    9. Ocular Redness at Day 27 [7, 15, 20 minutes post-CAC]

      Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.

    10. Ocular Redness at Day 28 [7, 15, 20 minutes post-CAC]

      Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • At least 18 years of age & either sex, any race

    • Willing and able to follow all instructions

    • Positive history of ocular allergies

    • Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

    Exclusion Criteria:

    • Have planned surgery during trial period

    • Female currently pregnant, planning a pregnancy or lactating

    • Use of disallowed medications

    • Have ocular infections, or ocular conditions that could affect study parameters

    • Have moderate to severe dry eye

    • Have used an investigational drug or device within 30 days of start of study

    • Female that is currently pregnant, planning a pregnancy or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmic Research Associates Andover Massachusetts United States 01810

    Sponsors and Collaborators

    • ORA, Inc.

    Investigators

    • Principal Investigator: Gail L Torkildsen, MD, American board of Ophthalmology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ORA, Inc.
    ClinicalTrials.gov Identifier:
    NCT00689078
    Other Study ID Numbers:
    • 08-003-05
    First Posted:
    Jun 3, 2008
    Last Update Posted:
    Sep 2, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by ORA, Inc.
    Allergic conjunctivitis
    Additional relevant MeSH terms:
    Conjunctivitis
    Conjunctivitis, Allergic
    Loteprednol Etabonate
    Prednisolone
    Methylprednisolone Acetate
    Methylprednisolone
    Methylprednisolone Hemisuccinate
    Prednisolone acetate
    Lubricant Eye Drops
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited from one site in the US.
    Pre-assignment Detail Participant flow and baseline characteristics are presented for the 36 subjects that met all inclusion and none of the exclusion criteria and were randomized to receive Pred Forte, Pred Mild, Alrex, or Tears Naturale. 36 subjects were enrolled, 4 discontinued, and 32 subjects completed the study.
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Period Title: Overall Study
    STARTED 9 9 9 9
    Intent to Treat 9 7 8 8
    COMPLETED 9 7 8 8
    NOT COMPLETED 0 2 1 1

    Baseline Characteristics

    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale (Placebo) Total
    Arm/Group Description Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. Total of all reporting groups
    Overall Participants 9 9 9 9 36
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    40.11
    (6.15)
    44.11
    (11.53)
    44.67
    (18.65)
    45.78
    (14.71)
    43.67
    (13.14)
    Sex: Female, Male (Count of Participants)
    Female
    4
    44.4%
    4
    44.4%
    5
    55.6%
    3
    33.3%
    16
    44.4%
    Male
    5
    55.6%
    5
    55.6%
    4
    44.4%
    6
    66.7%
    20
    55.6%

    Outcome Measures

    1. Primary Outcome
    Title Ocular Itching at Baseline (Day 0)
    Description A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
    Time Frame 3, 5, 7 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 9 9 9
    3 minutes post-CAC
    2.53
    (0.507)
    3.08
    (0.771)
    2.61
    (0.953)
    2.5
    (0.781)
    5 minutes post-CAC
    2.92
    (0.661)
    3.47
    (0.475)
    3.06
    (0.682)
    2.75
    (0.612)
    7 minutes post-CAC
    3.03
    (0.734)
    3.44
    (0.447)
    3.08
    (0.685)
    2.83
    (0.612)
    2. Primary Outcome
    Title Ocular Itching at Day 6
    Description Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
    Time Frame 3, 5, 7 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population (PP)
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 8 8 9
    3 minutes post-CAC
    2.17
    (0.781)
    2.19
    (1.108)
    2.06
    (0.904)
    2.33
    (0.76)
    5 minutes post-CAC
    2.44
    (0.778)
    2.59
    (0.954)
    2.41
    (0.963)
    2.53
    (0.824)
    7 minutes post-CAC
    2.17
    (0.968)
    2.72
    (0.891)
    2.31
    (1.007)
    2.14
    (0.674)
    3. Primary Outcome
    Title Ocular Itching at Day 7
    Description Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
    Time Frame 3, 5, 7 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population (PP)
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 8 8 9
    3 minutes post-CAC
    2.11
    (0.858)
    2.28
    (1.004)
    2.09
    (1.069)
    2.03
    (1.064)
    5 minutes post-CAC
    2.11
    (0.894)
    2.69
    (1.007)
    2.03
    (0.85)
    1.94
    (1.108)
    7 minutes post-CAC
    1.97
    (0.956)
    2.75
    (0.896)
    1.88
    (0.982)
    1.72
    (0.93)
    4. Primary Outcome
    Title Ocular Itching at Day 27
    Description Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
    Time Frame 3, 5, 7 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population (PP)
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 8 8 8
    3 minutes post-CAC
    2.14
    (1.119)
    2.43
    (1.231)
    1.75
    (1.433)
    2.03
    (0.871)
    5 minutes post-CAC
    2.17
    (1.281)
    2.64
    (1.189)
    2.09
    (1.239)
    1.84
    (0.801)
    7 minutes post-CAC
    2.03
    (1.314)
    2.64
    (1.189)
    2
    (1.382)
    1.72
    (0.807)
    5. Primary Outcome
    Title Ocular Itching at Day 28
    Description Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
    Time Frame 3, 5, 7 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT)
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 7 8 8
    3 minutes post-CAC
    1.83
    (1.111)
    2.25
    (1.267)
    2.03
    (1.404)
    1.75
    (0.835)
    5 minutes post-CAC
    1.97
    (1.343)
    2.64
    (1.24)
    2
    (1.482)
    1.78
    (0.901)
    7 minutes post-CAC
    1.89
    (1.426)
    2.71
    (1.228)
    1.78
    (1.417)
    1.56
    (0.853)
    6. Primary Outcome
    Title Ocular Redness at Baseline (Day 0)
    Description A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
    Time Frame 7, 15, 20 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 9 9 9
    7 minutes post-CAC
    2.11
    (0.651)
    2.11
    (0.532)
    1.86
    (0.333)
    2.08
    (0.354)
    15 minutes post-CAC
    2.33
    (0.573)
    2.31
    (0.349)
    2.11
    (0.182)
    2.25
    (0.415)
    20 minutes post-CAC
    2.22
    (0.537)
    2.28
    (0.384)
    2
    (0.125)
    2.06
    (0.41)
    7. Primary Outcome
    Title Ocular Redness at Day 6
    Description Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
    Time Frame 7, 15, 20 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population (PP)
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 8 8 9
    7 minutes post-CAC
    2
    (0.515)
    2.22
    (0.508)
    1.84
    (0.823)
    2.11
    (0.858)
    15 minutes post-CAC
    1.97
    (0.775)
    2.41
    (0.626)
    2.13
    (0.327)
    2.28
    (0.996)
    20 minutes post-CAC
    2
    (0.866)
    2.31
    (0.691)
    2.03
    (0.452)
    2.17
    (0.992)
    8. Primary Outcome
    Title Ocular Redness at Day 7
    Description Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
    Time Frame 7, 15, 20 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Per Protocol Population (PP)
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 8 8 9
    7 minutes post-CAC
    2.08
    (0.451)
    1.53
    (0.761)
    1.59
    (0.706)
    1.59
    (0.778)
    15 minutes post-CAC
    1.83
    (0.791)
    1.69
    (0.894)
    1.59
    (0.706)
    1.66
    (0.981)
    20 minutes post-CAC
    1.72
    (0.765)
    1.78
    (0.986)
    1.47
    (0.737)
    1.5
    (0.973)
    9. Primary Outcome
    Title Ocular Redness at Day 27
    Description Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
    Time Frame 7, 15, 20 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT)
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 7 8 8
    7 minutes post-CAC
    1.72
    (0.701)
    2.14
    (0.349)
    1.44
    (0.32)
    1.56
    (0.776)
    15 minutes post-CAC
    1.72
    (0.723)
    2.11
    (0.476)
    1.63
    (0.567)
    1.72
    (0.674)
    20 minutes post-CAC
    1.53
    (0.814)
    1.89
    (0.575)
    1.53
    (0.558)
    1.72
    (0.749)
    10. Primary Outcome
    Title Ocular Redness at Day 28
    Description Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
    Time Frame 7, 15, 20 minutes post-CAC

    Outcome Measure Data

    Analysis Population Description
    Intent to Treat (ITT)
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks 1 drop in each eye up to 4 times daily for up to 4 weeks
    Measure Participants 9 7 8 8
    7 minutes post-CAC
    1.58
    (0.82)
    1.96
    (0.393)
    1.69
    (0.637)
    1.81
    (0.788)
    15 minutes post-CAC
    1.81
    (0.827)
    2.11
    (0.378)
    1.69
    (0.753)
    1.94
    (0.863)
    20 minutes post-CAC
    1.5
    (0.791)
    1.86
    (0.476)
    1.69
    (0.717)
    1.72
    (0.761)

    Adverse Events

    Time Frame Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
    Adverse Event Reporting Description Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
    Arm/Group Title Pred Forte Pred Mild Alrex Tears Naturale
    Arm/Group Description 1 drop in each eye up to 4 times daily during a 4 week period 1 drop in each eye up to 4 times daily during a 4 week period 1 drop in each eye up to 4 times daily during a 4 week period 1 drop in each eye up to 4 times daily during a 4 week period
    All Cause Mortality
    Pred Forte Pred Mild Alrex Tears Naturale
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%)
    Serious Adverse Events
    Pred Forte Pred Mild Alrex Tears Naturale
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/9 (0%)
    Other (Not Including Serious) Adverse Events
    Pred Forte Pred Mild Alrex Tears Naturale
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/9 (33.3%) 4/9 (44.4%) 0/9 (0%) 2/9 (22.2%)
    Eye disorders
    Stinging upon instillation of dose 1 QD (Morning dose every day) 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0 0/9 (0%) 0
    Increase in IOP (5 unit) 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0 0/9 (0%) 0
    Burning upon instillation 0/9 (0%) 0 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0
    Lower lid swelling 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0 0/9 (0%) 0
    Ocular fatigue sensation 0/9 (0%) 0 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    General disorders
    Taste Perversion 0/9 (0%) 0 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0
    Worsening of Rhinitis 1 hour after instillation of Dose 1 0/9 (0%) 0 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    Worsening of Headache 0/9 (0%) 0 0/9 (0%) 0 0/9 (0%) 0 1/9 (11.1%) 1
    Taste perversion upon instillation 0/9 (0%) 0 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0
    Skin and subcutaneous tissue disorders
    Itching secondary to Posion Ivy 0/9 (0%) 0 1/9 (11.1%) 1 0/9 (0%) 0 0/9 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Paul Gomes
    Organization ORA
    Phone 9786858900
    Email pgomes@oraclinical.com
    Responsible Party:
    ORA, Inc.
    ClinicalTrials.gov Identifier:
    NCT00689078
    Other Study ID Numbers:
    • 08-003-05
    First Posted:
    Jun 3, 2008
    Last Update Posted:
    Sep 2, 2020
    Last Verified:
    Aug 1, 2020