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

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: NCT00689078
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.

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
Allergic Conjunctivitis 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)

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Study Type : Interventional  (Clinical Trial)
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 Prednisolone Acetate 1% Ophthalmic Suspension Compared to Prednisolone Acetate 0.12% Ophthalmic Suspension, Loteprednol Etabonate 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model
Study Start Date : May 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008


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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Ocular Itching at Baseline (Day 0) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00689078


Locations
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United States, Massachusetts
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ORA, Inc.
Investigators
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Principal Investigator: Gail L Torkildsen, MD Massachusetts Medical Society, Alpha Omega Honor Society, American board of Ophthalmology

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Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT00689078    
Other Study ID Numbers: 08-003-05
First Posted: June 3, 2008    Key Record Dates
Results First Posted: November 15, 2018
Last Update Posted: November 15, 2018
Last Verified: September 2017
Keywords provided by ORA, Inc.:
Allergic conjunctivitis
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loteprednol Etabonate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Lubricant Eye Drops
Prednisolone hemisuccinate
Prednisolone phosphate
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
Ophthalmic Solutions