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)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 10.8

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 Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	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 Naturale® 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

Arm	Intervention/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

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

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

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	Prednisolone	Placebo
Arm/Group Description	Prednisolone 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
STARTED	5	6
COMPLETED	4	5
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Prednisolone	Placebo	Total
Arm/Group Description	Prednisolone 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	Total of all reporting groups
Overall Participants	4	5	9
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

Title	Ocular Itching Change From Baseline to Day 11
Description	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).
Time Frame	5 minutes post-CAC

Outcome Measure Data

Analysis Population Description

All participants who completed the study

Arm/Group Title	Prednisolone	Placebo
Arm/Group Description	Prednisolone 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 Participants	4	5
Mean (Standard Deviation) [units on a scale]	-1.1 (0.14)	-0.45 (0.86)

2. Secondary Outcome

Title	Conjunctival Redness Change From Baseline to Day 11
Description	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)
Time Frame	7 Minutes post-CAC

Outcome Measure Data

Analysis Population Description

All participants who completed the study

Arm/Group Title	Prednisolone	Placebo
Arm/Group Description	Prednisolone 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 Participants	4	5
Mean (Standard Deviation) [score on a scale]	-0.69 (0.31)	0.40 (0.88)

3. Secondary Outcome

Title	Episcleral Redness Change From Baseline to Day 6
Description	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).
Time Frame	7 minutes post-CAC

Outcome Measure Data

Analysis Population Description

All participants who completed the study

Arm/Group Title	Prednisolone	Placebo
Arm/Group Description	Prednisolone 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 Participants	4	5
Mean (Standard Deviation) [score on a scale]	-1.0 (0.41)	0.45 (0.93)

4. Secondary Outcome

Title	Ciliary Redness Change From Baseline to Day 6
Description	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).
Time Frame	7 minutes post-CAC

Outcome Measure Data

Analysis Population Description

All participants who completed the study

Arm/Group Title	Prednisolone	Placebo
Arm/Group Description	Prednisolone 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 Participants	4	5
Mean (Standard Deviation) [score on a scale]	-0.94 (0.66)	0.30 (0.96)

Adverse Events

Time Frame	AEs were collected from the date of informed consent to the date of the final visit (1 month).
Arm/Group Title	Prednisolone		Placebo
Arm/Group Description	Prednisolone 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
	Prednisolone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/6 (0%)
Serious Adverse Events
	Prednisolone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Prednisolone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/5 (20%)		3/6 (50%)
Eye disorders
Mucous Discharge (OU)	0/5 (0%)	0	2/6 (33.3%)	2
Musculoskeletal and connective tissue disorders
Headache	1/5 (20%)	1	0/6 (0%)	0
Backache	0/5 (0%)	0	1/6 (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.