Trial Outcomes & Findings for A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis (NCT NCT01732757)

NCT ID: NCT01732757

Last Updated: 2014-01-14

Results Overview

Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 157 participants
• Primary outcome timeframe: Day 0 at 3 Minutes Post Challenge
• Results posted on: 2014-01-14

Participant Flow

Participant milestones

Measure	Lastacaft® One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Overall Study STARTED	53	52	52
Overall Study COMPLETED	52	52	52
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	Lastacaft® One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis

Baseline characteristics by cohort

Measure	Lastacaft® n=53 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.	Total n=157 Participants Total of all reporting groups
Age, Continuous	38.2 Years STANDARD_DEVIATION 13.78 • n=5 Participants	38.7 Years STANDARD_DEVIATION 15.10 • n=7 Participants	34.7 Years STANDARD_DEVIATION 12.58 • n=5 Participants	37.2 Years STANDARD_DEVIATION 13.88 • n=4 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	29 Participants n=7 Participants	26 Participants n=5 Participants	87 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	26 Participants n=5 Participants	70 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 0 at 3 Minutes Post Challenge

Population: All randomized subjects with data at this time point

Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0	0.40 Scores on a Scale Standard Deviation 0.582	0.76 Scores on a Scale Standard Deviation 0.752	2.00 Scores on a Scale Standard Deviation 1.109

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 7 Minutes	0.69 Scores on a Scale Standard Deviation 0.724	0.71 Scores on a Scale Standard Deviation 0.774	1.89 Scores on a Scale Standard Deviation 1.114
Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 5 Minutes	0.61 Scores on a Scale Standard Deviation 0.663	0.79 Scores on a Scale Standard Deviation 0.725	2.08 Scores on a Scale Standard Deviation 1.061

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 3 Minutes	84.6 Percentage of Subjects	65.4 Percentage of Subjects	21.2 Percentage of Subjects
Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 5 Minutes	75.0 Percentage of Subjects	53.8 Percentage of Subjects	21.2 Percentage of Subjects
Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 7 Minutes	69.2 Percentage of Subjects	61.5 Percentage of Subjects	25.0 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 3 Minutes	48.1 Percentage of Subjects	26.9 Percentage of Subjects	5.8 Percentage of Subjects
Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 5 Minutes	26.9 Percentage of Subjects	26.9 Percentage of Subjects	3.8 Percentage of Subjects
Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 7 Minutes	26.9 Percentage of Subjects	32.7 Percentage of Subjects	7.7 Percentage of Subjects

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).

Outcome measures

Measure	Lastacaft® n=104 Eyes One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=104 Eyes One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=104 Eyes One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 3.5	0.0 Percentage of Subject Eyes	0.0 Percentage of Subject Eyes	5.8 Percentage of Subject Eyes
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 0	41.7 Percentage of Subject Eyes	34.3 Percentage of Subject Eyes	8.7 Percentage of Subject Eyes
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 0.5	32.1 Percentage of Subject Eyes	24.0 Percentage of Subject Eyes	10.9 Percentage of Subject Eyes
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 1.0	12.5 Percentage of Subject Eyes	20.8 Percentage of Subject Eyes	8.0 Percentage of Subject Eyes
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 1.5	3.5 Percentage of Subject Eyes	7.7 Percentage of Subject Eyes	6.4 Percentage of Subject Eyes
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 2.0	5.8 Percentage of Subject Eyes	6.7 Percentage of Subject Eyes	17.9 Percentage of Subject Eyes
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 2.5	4.2 Percentage of Subject Eyes	5.1 Percentage of Subject Eyes	22.8 Percentage of Subject Eyes
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 3.0	0.3 Percentage of Subject Eyes	1.3 Percentage of Subject Eyes	15.1 Percentage of Subject Eyes
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 4.0	0.0 Percentage of Subject Eyes	0.0 Percentage of Subject Eyes	4.5 Percentage of Subject Eyes

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 7 Minutes	1.73 Scores on a Scale Standard Deviation 0.887	1.61 Scores on a Scale Standard Deviation 0.867	2.17 Scores on a Scale Standard Deviation 0.731
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 15 Minutes	2.02 Scores on a Scale Standard Deviation 0.844	1.81 Scores on a Scale Standard Deviation 0.877	2.17 Scores on a Scale Standard Deviation 0.784
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 20 Minutes	2.10 Scores on a Scale Standard Deviation 0.854	1.89 Scores on a Scale Standard Deviation 0.886	2.22 Scores on a Scale Standard Deviation 0.830

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 20 Minutes	2.06 Scores on a Scale Standard Deviation 0.831	1.78 Scores on a Scale Standard Deviation 0.913	2.13 Scores on a Scale Standard Deviation 0.903
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 7 Minutes	1.62 Scores on a Scale Standard Deviation 0.889	1.47 Scores on a Scale Standard Deviation 0.887	2.10 Scores on a Scale Standard Deviation 0.805
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 15 Minutes	1.97 Scores on a Scale Standard Deviation 0.845	1.71 Scores on a Scale Standard Deviation 0.912	2.12 Scores on a Scale Standard Deviation 0.832

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 7 Minutes	1.61 Scores on a Scale Standard Deviation 0.842	1.53 Scores on a Scale Standard Deviation 0.815	2.04 Scores on a Scale Standard Deviation 0.755
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 15 Minutes	1.88 Scores on a Scale Standard Deviation 0.820	1.70 Scores on a Scale Standard Deviation 0.839	2.04 Scores on a Scale Standard Deviation 0.828
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 20 Minutes	1.97 Scores on a Scale Standard Deviation 0.837	1.78 Scores on a Scale Standard Deviation 0.874	2.09 Scores on a Scale Standard Deviation 0.837

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 7 Minutes	0.37 Scores on a Scale Standard Deviation 0.433	0.27 Scores on a Scale Standard Deviation 0.350	0.51 Scores on a Scale Standard Deviation 0.511
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 15 Minutes	0.62 Scores on a Scale Standard Deviation 0.576	0.51 Scores on a Scale Standard Deviation 0.562	0.76 Scores on a Scale Standard Deviation 0.691
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 20 Minutes	0.73 Scores on a Scale Standard Deviation 0.679	0.56 Scores on a Scale Standard Deviation 0.634	0.96 Scores on a Scale Standard Deviation 0.757

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 7 Minutes	0.2 Scores on a Scale Standard Deviation 0.48	0.3 Scores on a Scale Standard Deviation 0.54	0.8 Scores on a Scale Standard Deviation 0.70
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 15 Minutes	0.4 Scores on a Scale Standard Deviation 0.51	0.5 Scores on a Scale Standard Deviation 0.70	0.9 Scores on a Scale Standard Deviation 0.78
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 20 Minutes	0.4 Scores on a Scale Standard Deviation 0.51	0.6 Scores on a Scale Standard Deviation 0.85	0.7 Scores on a Scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Day 0

Population: All randomized subjects with data at this time point

Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.

Outcome measures

Measure	Lastacaft® n=52 Participants One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Pataday™ n=52 Participants One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n=52 Participants One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 7 Minutes	0.2 Scores on a Scale Standard Deviation 0.40	0.4 Scores on a Scale Standard Deviation 0.59	0.9 Scores on a Scale Standard Deviation 0.84
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 15 Minutes	0.4 Scores on a Scale Standard Deviation 0.58	0.5 Scores on a Scale Standard Deviation 0.77	0.8 Scores on a Scale Standard Deviation 0.93
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 20 Minutes	0.3 Scores on a Scale Standard Deviation 0.57	0.6 Scores on a Scale Standard Deviation 0.83	0.7 Scores on a Scale Standard Deviation 0.94

Adverse Events

Lastacaft®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pataday™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER