Trial Outcomes & Findings for Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model (NCT NCT01534195)

NCT ID: NCT01534195

Last Updated: 2019-03-26

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 5 minutes post-CAC
• Results posted on: 2019-03-26

Participant Flow

Participant milestones

Measure	Prednisolone Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye four times/day (QID) for 8 days.	Placebo Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Overall Study STARTED	5	6
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Prednisolone Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye four times/day (QID) for 8 days.	Placebo Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Prednisolone n=4 Participants Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.	Placebo n=5 Participants Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	49.6 years STANDARD_DEVIATION 6.693 • n=5 Participants	49.5 years STANDARD_DEVIATION 13.329 • n=7 Participants	49.55 years STANDARD_DEVIATION 8.896 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes post-CAC

Population: All participants who completed the study

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).

Outcome measures

Measure	Prednisolone n=4 Participants Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.	Placebo n=5 Participants Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Ocular Itching Change From Baseline to Day 11	-1.1 units on a scale Standard Deviation 0.14	-0.45 units on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: 7 Minutes post-CAC

Population: All participants who completed the study

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)

Outcome measures

Measure	Prednisolone n=4 Participants Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.	Placebo n=5 Participants Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Conjunctival Redness Change From Baseline to Day 11	-0.69 score on a scale Standard Deviation 0.31	0.40 score on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: 7 minutes post-CAC

Population: All participants who completed the study

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).

Outcome measures

Measure	Prednisolone n=4 Participants Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.	Placebo n=5 Participants Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Episcleral Redness Change From Baseline to Day 6	-1.0 score on a scale Standard Deviation 0.41	0.45 score on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: 7 minutes post-CAC

Population: All participants who completed the study

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).

Outcome measures

Measure	Prednisolone n=4 Participants Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye QID for 8 days.	Placebo n=5 Participants Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye QID for 8 days
Ciliary Redness Change From Baseline to Day 6	-0.94 score on a scale Standard Deviation 0.66	0.30 score on a scale Standard Deviation 0.96

Adverse Events

Prednisolone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prednisolone n=5 participants at risk Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 8 days.	Placebo n=6 participants at risk Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 8 days
Eye disorders Mucous Discharge (OU)	0.00% 0/5 • AEs were collected from the date of informed consent to the date of the final visit (1 month).	33.3% 2/6 • Number of events 2 • AEs were collected from the date of informed consent to the date of the final visit (1 month).
Musculoskeletal and connective tissue disorders Headache	20.0% 1/5 • Number of events 1 • AEs were collected from the date of informed consent to the date of the final visit (1 month).	0.00% 0/6 • AEs were collected from the date of informed consent to the date of the final visit (1 month).
Musculoskeletal and connective tissue disorders Backache	0.00% 0/5 • AEs were collected from the date of informed consent to the date of the final visit (1 month).	16.7% 1/6 • Number of events 1 • AEs were collected from the date of informed consent to the date of the final visit (1 month).

Additional Information

Keith Lane

Ora

Phone: 9786896500

Email: klane@oraclinical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place