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
NCT01534195
Collaborator
(none)
11
Enrollment
1
Location
2
Arms
1
Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:
  • Ocular itching

  • Conjunctival redness

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
  • Drug: Tears Naturale II Ophthalmic Solution
Phase 4

Detailed Description

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 8 days between Visits 4 and 5.

  • Prednisolone phosphate

  • Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 19 days

Controls:

Artificial Tears (Tears NaturaleĀ® II)

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

ArmIntervention/Treatment
Experimental: Prednisolone

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
One drop in each eye, four times/day for 8 days.

Placebo Comparator: Placebo

Tears Naturale II Ophthalmic Solution, 1%

Drug: Tears Naturale II Ophthalmic Solution
one drop in each eye, four times/ day (QID) for 8 days

Outcome Measures

Primary Outcome Measures

  1. Ocular Itching Change From Baseline to Day 11 [5 minutes post-CAC]

    Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).

Secondary Outcome Measures

  1. Conjunctival Redness Change From Baseline to Day 11 [7 Minutes post-CAC]

    Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)

  2. Episcleral Redness Change From Baseline to Day 6 [7 minutes post-CAC]

    Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).

  3. Ciliary Redness Change From Baseline to Day 6 [7 minutes post-CAC]

    Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).

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

SiteCityStateCountryPostal Code
1Andover Eye AssociatesAndoverMassachusettsUnited States01810

Sponsors and Collaborators

  • ORA, Inc.

Investigators

  • Principal Investigator: Tarek Shazly, MD, Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01534195
Other Study ID Numbers:
  • 12-270-0001
First Posted:
Feb 16, 2012
Last Update Posted:
Mar 26, 2019
Last Verified:
Jul 1, 2012

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitlePrednisolonePlacebo
Arm/Group DescriptionPrednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye four times/day (QID) for 8 days.Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Period Title: Overall Study
STARTED56
COMPLETED45
NOT COMPLETED11

Baseline Characteristics

Arm/Group TitlePrednisolonePlaceboTotal
Arm/Group DescriptionPrednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 daysTotal of all reporting groups
Overall Participants459
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
4
100%
4
80%
8
88.9%
>=65 years
0
0%
1
20%
1
11.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
49.6
(6.693)
49.5
(13.329)
49.55
(8.896)
Sex: Female, Male (Count of Participants)
Female
2
50%
3
60%
5
55.6%
Male
2
50%
2
40%
4
44.4%
Region of Enrollment (participants) [Number]
United States
4
100%
5
100%
9
100%

Outcome Measures

1. Primary Outcome
TitleOcular Itching Change From Baseline to Day 11
DescriptionOcular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
Time Frame5 minutes post-CAC

Outcome Measure Data

Analysis Population Description
All participants who completed the study
Arm/Group TitlePrednisolonePlacebo
Arm/Group DescriptionPrednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Measure Participants45
Mean (Standard Deviation) [units on a scale]
-1.1
(0.14)
-0.45
(0.86)
2. Secondary Outcome
TitleConjunctival Redness Change From Baseline to Day 11
DescriptionConjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)
Time Frame7 Minutes post-CAC

Outcome Measure Data

Analysis Population Description
All participants who completed the study
Arm/Group TitlePrednisolonePlacebo
Arm/Group DescriptionPrednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Measure Participants45
Mean (Standard Deviation) [score on a scale]
-0.69
(0.31)
0.40
(0.88)
3. Secondary Outcome
TitleEpiscleral Redness Change From Baseline to Day 6
DescriptionEpiscleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).
Time Frame7 minutes post-CAC

Outcome Measure Data

Analysis Population Description
All participants who completed the study
Arm/Group TitlePrednisolonePlacebo
Arm/Group DescriptionPrednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Measure Participants45
Mean (Standard Deviation) [score on a scale]
-1.0
(0.41)
0.45
(0.93)
4. Secondary Outcome
TitleCiliary Redness Change From Baseline to Day 6
DescriptionCiliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).
Time Frame7 minutes post-CAC

Outcome Measure Data

Analysis Population Description
All participants who completed the study
Arm/Group TitlePrednisolonePlacebo
Arm/Group DescriptionPrednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Measure Participants45
Mean (Standard Deviation) [score on a scale]
-0.94
(0.66)
0.30
(0.96)

Adverse Events

Time FrameAEs were collected from the date of informed consent to the date of the final visit (1 month).
Adverse Event Reporting Description
Arm/Group TitlePrednisolonePlacebo
Arm/Group DescriptionPrednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 8 days.Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 8 days
All Cause Mortality
PrednisolonePlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/5 (0%) 0/6 (0%)
Serious Adverse Events
PrednisolonePlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/5 (0%) 0/6 (0%)
Other (Not Including Serious) Adverse Events
PrednisolonePlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/5 (20%) 3/6 (50%)
Eye disorders
Mucous Discharge (OU)0/5 (0%) 02/6 (33.3%) 2
Musculoskeletal and connective tissue disorders
Headache1/5 (20%) 10/6 (0%) 0
Backache0/5 (0%) 01/6 (16.7%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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/TitleKeith Lane
OrganizationOra
Phone9786896500
Emailklane@oraclinical.com
Responsible Party:
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01534195
Other Study ID Numbers:
  • 12-270-0001
First Posted:
Feb 16, 2012
Last Update Posted:
Mar 26, 2019
Last Verified:
Jul 1, 2012