Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
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| ClinicalTrials.gov Identifier: NCT01730872 |
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Recruitment Status :
Completed
First Posted : November 21, 2012
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
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The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,
Prednisolone, assessed by the following measures:
Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Allergic Conjunctivitis | Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1% Drug: Tears Naturale II Ophthalmic Solution | Phase 4 |
Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4.
Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)
Duration:
Approximately 2 weeks
Controls:
Artificial Tears (Tears Naturale® II)
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model |
| Study Start Date : | November 2012 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Prednisolone
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
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Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
One drop in each eye, four times/day for 4 days. |
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Placebo Comparator: Placebo
Tears Naturale II Ophthalmic Solution, 1%
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Drug: Tears Naturale II Ophthalmic Solution
one drop in each eye, four times/ day (QID) for 4 days |
- Inflammation Change From Baseline to Day 6 [ Time Frame: 90 minutes post CAC ]Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
- Ocular Itching Change From Baseline to Day 6 [ Time Frame: 7 minutes post-CAC ]Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC
- Ocular Redness Change From Baseline to Day 6 [ Time Frame: 7 minutes post-CAC ]Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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): NCT01730872
| United States, Massachusetts | |
| Andover Eye Associates | |
| Andover, Massachusetts, United States, 01810 | |
| Principal Investigator: | Gail Torkildsen, MD | Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology |
| Responsible Party: | ORA, Inc. |
| ClinicalTrials.gov Identifier: | NCT01730872 |
| Other Study ID Numbers: |
12-270-0007 |
| First Posted: | November 21, 2012 Key Record Dates |
| Results First Posted: | June 19, 2019 |
| Last Update Posted: | June 19, 2019 |
| Last Verified: | June 2019 |
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Conjunctivitis Conjunctivitis, Allergic Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Pharmaceutical Solutions Ophthalmic Solutions 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 |