Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease

• Sponsor: Oyster Point Pharma, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04036292
• Collaborator: (none)
• Enrollment: 758
• Locations: 22
• Arms: 3
• Actual Duration (Months): 18.5
• Patients Per Site: 34.5
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease (DED)	Drug: OC-01 (varenicline) nasal spray; Drug: Placebo (vehicle) nasal spray	Phase 3

Detailed Description

This was a Phase 3, multicenter, randomized, controlled, double-masked (including subjects, Investigators, study site personnel, and Sponsor personnel) study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray 0.6 mg/mL and 1.2 mg/mL in adult participants with DED. The study randomized 758 subjects at least 22 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria to receive OC-01 (varenicline) nasal spray or placebo twice daily (BID) for 28 days with three additional long-term follow-up visits at 6 weeks, 6 months, and 12 months. Participants who terminated from the study during the treatment period were asked to complete safety assessments (if the participants agree) prior to study exit. Participants who were terminated early from the study were not replaced

Study Design

• Study Type: Interventional
• Actual Enrollment: 758 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Multicenter, Randomized, Controlled, Double-Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-2 Study)
• Actual Study Start Date: Jul 23, 2019
• Actual Primary Completion Date: Apr 10, 2020
• Actual Study Completion Date: Feb 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OC-01 Low Dose, 0.6 mg/mL OC-01 (varenicline) nasal spray, 0.6 mg/ML	Drug: OC-01 (varenicline) nasal spray; OC-01 (varenicline) nasal spray
Active Comparator: OC-01 High Dose, 1.2 mg/mL OC-01 (varenicline) nasal spray, 1.2 mg/ML	Drug: OC-01 (varenicline) nasal spray; OC-01 (varenicline) nasal spray
Placebo Comparator: Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray	Drug: Placebo (vehicle) nasal spray; Placebo (vehicle) nasal spray

Outcome Measures

Primary Outcome Measures

1. Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28) [28 Days [Visit 1 (baseline) and Visit 4b (28 days)]]

   The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.

Secondary Outcome Measures

1. Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes [28 Days [Visit 1 (baseline) and Visit 4a (28 days)]]

   Change in Eye Dryness Score Eye from baseline in CAE at 4 Weeks at 5 minutes post treatment. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.

2. Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28 [28 Days [Visit 1 (baseline) and Visit 4b (28 days)]]

   Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.

3. Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28 [28 Days [Visit 1 (baseline) and Visit 4b (28 days)]]

   Change in Schirmer test score from baseline to Day 28. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.

4. Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2 [14 Days [Visit 1 (baseline) and Visit 3 (14 days)]]

   Chang in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better otucome.

5. Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1 [7 Days [Visit 1 (baseline) and Visit 2 (7 days)]]

   Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

Exclusion Criteria:

• Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1.

• Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with dry eye disease are allowed.

• Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)

• Have a known hypersensitivity to any of the procedural agents or study drug components

• Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix	Phoenix	Arizona	United States	85032
2	New Port Beach	Newport Beach	California	United States	92663
3	Fort Collins	Fort Collins	Colorado	United States	80528
4	Waterbury	Waterbury	Connecticut	United States	06708
5	Delray Beach	Delray Beach	Florida	United States	33484
6	Indianapolis	Indianapolis	Indiana	United States	46290
7	Louisville	Louisville	Kentucky	United States	40206
8	Raynham	Raynham	Massachusetts	United States	02767
9	Las Vegas	Las Vegas	Nevada	United States	89052
10	Raleigh	Raleigh	North Carolina	United States	27603
11	Shelby	Shelby	North Carolina	United States	28150
12	Fargo	Fargo	North Dakota	United States	58103
13	Cranberry Township	Cranberry Township	Pennsylvania	United States	16066
14	Warwick	Warwick	Rhode Island	United States	02842
15	Sioux Falls	Sioux Falls	South Dakota	United States	57108
16	Nashville	Nashville	Tennessee	United States	37210
17	Austin	Austin	Texas	United States	78731
18	Houston	Houston	Texas	United States	77025
19	San Antonio	San Antonio	Texas	United States	78209
20	San Antonio	San Antonio	Texas	United States	78229
21	Layton	Layton	Utah	United States	84041
22	Lynchburg	Lynchburg	Virginia	United States	24502

Sponsors and Collaborators

• Oyster Point Pharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Sep 18, 2019
• Statistical Analysis Plan - Apr 29, 2020

More Information

Publications

None provided.

• Responsible Party: Oyster Point Pharma, Inc.
• ClinicalTrials.gov Identifier: NCT04036292
• Other Study ID Numbers: OPP-101
• First Posted: Jul 29, 2019
• Last Update Posted: Nov 22, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Varenicline

Study Results

Participant Flow

Arm/Group Title	OC-01 Low Dose 0.6 mg/mL BID for 28 Days	OC-01 High Dose 1.2 mg/mL BID for 28 Days	Placebo BID for 28 Days
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML BID for 28 days	OC-01 (varenicline) nasal spray 1.2 mg/mL BID for 28 days	Placebo (vehicle) nasal spray BID for 28 days
Period Title: Overall Study
STARTED	260	246	252
COMPLETED	239	212	228
NOT COMPLETED	21	34	24

Baseline Characteristics

Arm/Group Title	OC-01 Low Dose 0.6 mg/mL BID for 28 Days	OC-01 High Dose 1.2 mg/mL BID for 28 Days	Placebo (Vehicle) Nasal Spray BID for 28 Days	Total
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML BID for 28 days OC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray, 1.2 mg/ML BID for 28 days OC-01 (varenicline) nasal spray: OC-01 (varenicline) nasal spray	Placebo (vehicle) nasal spray BID for 28 days Placebo (vehicle) nasal spray: Placebo (vehicle) nasal spray	Total of all reporting groups
Overall Participants	260	246	252	758
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.6 (12.76)	58.4 (13.03)	58.4 (13.29)	58.8 (13.02)
Sex: Female, Male (Count of Participants)
Female	194 74.6%	181 73.6%	201 79.8%	576 76%
Male	66 25.4%	65 26.4%	51 20.2%	182 24%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 10.4%	37 15%	36 14.3%	100 13.2%
Not Hispanic or Latino	233 89.6%	209 85%	216 85.7%	658 86.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	1 0.4%	2 0.8%	6 2.4%	9 1.2%
Asian	11 4.2%	7 2.8%	5 2%	23 3%
Black or African American	27 10.4%	35 14.2%	29 11.5%	91 12%
Native Hawaiian or other Pacific Islander	2 0.8%	0 0%	1 0.4%	3 0.4%
White	219 84.2%	200 81.3%	211 83.7%	630 83.1%
Other	0 0%	2 0.8%	0 0%	2 0.3%
Region of Enrollment (participants) [Number]
United States	260 100%	246 100%	252 100%	758 100%
Baseline Schirmer's Test Score (mm) (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	5.1 (2.95)	5.4 (2.93)	4.9 (2.89)	5.1 (2.93)

Outcome Measures

1. Primary Outcome

Title	Percent of Subjects Who Achieve ≥10 mm Improvement in Schirmer's Test Score From Baseline at Visit 4 (Day 28)
Description	The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Time Frame	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]

Outcome Measure Data

Analysis Population Description

Subjects in the ITT-LOCF population

Arm/Group Title	OC-01 Low Dose, 0.6 mg/mL	OC-01 High Dose, 1.2 mg/mL	Placebo (Vehicle) Nasal Spray
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML OC-01 (varenicline) nasal spray	OC-01 (varenicline) nasal spray, 1.2 mg/ML OC-01 (varenicline) nasal spray	Placebo (vehicle) nasal spray Placebo (vehicle) nasal spray
Measure Participants	260	246	252
Count of Participants [Participants]	123 47.3%	121 49.2%	70 27.8%

2. Secondary Outcome

Title	Mean Change From Baseline in Eye Dryness Score in CAE at Week 4 at 5 Minutes
Description	Change in Eye Dryness Score Eye from baseline in CAE at 4 Weeks at 5 minutes post treatment. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Time Frame	28 Days [Visit 1 (baseline) and Visit 4a (28 days)]

Outcome Measure Data

Analysis Population Description

Subjects in the mITT-2 population

Arm/Group Title	OC-01 Low Dose, 0.6 mg/mL	OC-01 High Dose, 1.2 mg/mL	Placebo
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML	OC-01 (varenicline) nasal spray, 1.2 mg/ML	Placebo (vehicle) nasal spray
Measure Participants	187	171	169
Least Squares Mean (Standard Error) [mm]	-10.3 (1.62)	-9.0 (1.75)	-7.4 (1.74)

3. Secondary Outcome

Title	Mean Change From Baseline in Eye Dryness Score From Baseline to Day 28
Description	Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Time Frame	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]

Outcome Measure Data

Analysis Population Description

Subjects in the ITT-LOCF population

Arm/Group Title	OC-01 Low Dose, 0.6 mg/mL	OC-01 High Dose, 1.2 mg/mL	Placebo
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML	OC-01 (varenicline) nasal spray, 1.2 mg/ML	Placebo (vehicle) nasal spray
Measure Participants	255	242	248
Least Squares Mean (Standard Error) [mm]	-19.8 (1.54)	-22.2 (1.61)	-15.4 (1.57)

4. Secondary Outcome

Title	Mean Change Form Baseline in Schirmer's Test Score From Baseline to Day 28
Description	Change in Schirmer test score from baseline to Day 28. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Time Frame	28 Days [Visit 1 (baseline) and Visit 4b (28 days)]

Outcome Measure Data

Analysis Population Description

Subjects in the ITT-LOCF population

Arm/Group Title	OC-01 Low Dose, 0.6 mg/mL	OC-01 High Dose, 1.2 mg/mL	Placebo
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML	OC-01 (varenicline) nasal spray, 1.2 mg/ML	Placebo (vehicle) nasal spray
Measure Participants	251	235	248
Least Squares Mean (Standard Error) [mm]	11.3 (0.61)	11.5 (0.64)	6.3 (0.61)

5. Secondary Outcome

Title	Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 2
Description	Chang in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better otucome.
Time Frame	14 Days [Visit 1 (baseline) and Visit 3 (14 days)]

Outcome Measure Data

Analysis Population Description

Subjects in the ITT-LOCF population

Arm/Group Title	OC-01 Low Dose, 0.6 mg/mL	OC-01 High Dose, 1.2 mg/mL	Placebo
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML	OC-01 (varenicline) nasal spray, 1.2 mg/ML	Placebo (vehicle) nasal spray
Measure Participants	255	239	248
Least Squares Mean (Standard Error) [mm]	-16.5 (1.38)	-17.9 (1.45)	-12.7 (1.41)

6. Secondary Outcome

Title	Mean Change From Baseline in Eye Dryness Score in the Study Eye at Week 1
Description	Change in Eye Dryness Score Eye from baseline to 28 days. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no dryness) to 100 (maximum dryness) millimeters where a lower score is indicative of a better outcome.
Time Frame	7 Days [Visit 1 (baseline) and Visit 2 (7 days)]

Outcome Measure Data

Analysis Population Description

Subjects in the ITT population

Arm/Group Title	OC-01 Low Dose, 0.6 mg/mL	OC-01 High Dose, 1.2 mg/mL	Placebo
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML	OC-01 (varenicline) nasal spray, 1.2 mg/ML	Placebo (vehicle) nasal spray
Measure Participants	254	239	248
Least Squares Mean (Standard Error) [mm]	-15.7 (1.33)	-15.4 (1.40)	-13.3 (1.35)

Adverse Events

Time Frame	Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 7
Arm/Group Title	OC-01 Low Dose, 0.6 mg/mL		OC-01 High Dose, 1.2 mg/mL		Placebo
Arm/Group Description	OC-01 (varenicline) nasal spray, 0.6 mg/ML		OC-01 (varenicline) nasal spray, 1.2 mg/ML		Placebo (vehicle) nasal spray
All Cause Mortality
	OC-01 Low Dose, 0.6 mg/mL		OC-01 High Dose, 1.2 mg/mL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/260 (0%)		2/245 (0.8%)		1/251 (0.4%)
Serious Adverse Events
	OC-01 Low Dose, 0.6 mg/mL		OC-01 High Dose, 1.2 mg/mL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/260 (1.9%)		12/245 (4.9%)		9/251 (3.6%)
Cardiac disorders
Atrial fibrillation	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Atrioventricular block complete	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Bradycardia	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Coronary artery disease	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Myocardial infarction	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Congenital, familial and genetic disorders
Arnold-Chiari malformation	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Gastrointestinal disorders
Umbilical hernia	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Hepatobiliary disorders
Cholecystitis acute	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Infections and infestations
Coronavirus infection	0/260 (0%)		1/245 (0.4%)		1/251 (0.4%)
Sepsis	1/260 (0.4%)		0/245 (0%)		1/251 (0.4%)
Diabetic gangrene	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Gangrene	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Osteomyelitis	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Pneumonia	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Pneumonia bacterial	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Injury, poisoning and procedural complications
Humerus fracture	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Lumbar spinal stenosis	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Pancreatic carcinoma	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Nervous system disorders
Cerebrovascular accident	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Transient ischemic attack	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Renal and urinary disorders
Renal haematoma	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Surgical and medical procedures
Hip surgery	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Vascular disorders
Deep vein thrombosis	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Hypertensive urgency	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Other (Not Including Serious) Adverse Events
	OC-01 Low Dose, 0.6 mg/mL		OC-01 High Dose, 1.2 mg/mL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	253/260 (97.3%)		243/245 (99.2%)		158/251 (62.9%)
Congenital, familial and genetic disorders
Corneal dystrophy	1/260 (0.4%)		0/245 (0%)		1/251 (0.4%)
Eye disorders
conjunctival hyperaemia	12/260 (4.6%)		11/245 (4.5%)		7/251 (2.8%)
Visual acuity reduced	9/260 (3.5%)		9/245 (3.7%)		11/251 (4.4%)
Blepharitis	3/260 (1.2%)		1/245 (0.4%)		3/251 (1.2%)
Pinguecula	1/260 (0.4%)		3/245 (1.2%)		2/251 (0.8%)
Cataract	2/260 (0.8%)		0/245 (0%)		3/251 (1.2%)
Conjunctival haemorrage	1/260 (0.4%)		1/245 (0.4%)		3/251 (1.2%)
Eye irritation	1/260 (0.4%)		1/245 (0.4%)		3/251 (1.2%)
Posterior capsule opacification	0/260 (0%)		2/245 (0.8%)		3/251 (1.2%)
Meibomian gland dysfunction	1/260 (0.4%)		2/245 (0.8%)		1/251 (0.4%)
Cataract nuclear	1/260 (0.4%)		1/245 (0.4%)		1/251 (0.4%)
Eye pruritus	1/260 (0.4%)		2/245 (0.8%)		0/251 (0%)
Lacrimation increased	1/260 (0.4%)		1/245 (0.4%)		1/251 (0.4%)
Arcus lipoides	0/260 (0%)		1/245 (0.4%)		1/251 (0.4%)
Chalazion	1/260 (0.4%)		0/245 (0%)		1/251 (0.4%)
Conjunctival disorder	1/260 (0.4%)		1/245 (0.4%)		0/251 (0%)
Conjunctivitis allergic	0/260 (0%)		1/245 (0.4%)		1/251 (0.4%)
Erythema of eyelid	1/260 (0.4%)		1/245 (0.4%)		0/251 (0%)
Eye pain	0/260 (0%)		1/245 (0.4%)		1/251 (0.4%)
Ocular hyperaemia	0/260 (0%)		2/245 (0.8%)		0/251 (0%)
Punctate keratitis	1/260 (0.4%)		0/245 (0%)		1/251 (0.4%)
Swelling of eyelid	1/260 (0.4%)		1/245 (0.4%)		0/251 (0%)
Vision blurred	0/260 (0%)		1/245 (0.4%)		1/251 (0.4%)
Cataract subcapsular	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Conjunctival oedema	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
corneal epithelium defect	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
corneal opacity	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Diabetic retinal oedema	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Dry Eye	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Ectropion	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Eye discharge	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Eye inflammation	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Eyelid cyst	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Eyelid margin crusting	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Eyelid oedema	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Glare	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Keratopathy	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Macular hole	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Ocular hypertension	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Photopsia	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Trichiasis	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Visual impairement	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Vitreous detachment	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Vitreous floaters	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Gastrointestinal disorders
Nausea	1/260 (0.4%)		5/245 (2%)		1/251 (0.4%)
Abdominal pain upper	0/260 (0%)		3/245 (1.2%)		0/251 (0%)
General disorders
Instillation site irritation	21/260 (8.1%)		36/245 (14.7%)		3/251 (1.2%)
Immune system disorders
Seasonal allergy	1/260 (0.4%)		3/245 (1.2%)		0/251 (0%)
Infections and infestations
Hordeolum	3/260 (1.2%)		2/245 (0.8%)		2/251 (0.8%)
Conjunctivitis bacterial	1/260 (0.4%)		0/245 (0%)		1/251 (0.4%)
Conjunctivitis viral	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Nasopharyngitis	9/260 (3.5%)		16/245 (6.5%)		14/251 (5.6%)
Sinusitis	0/260 (0%)		5/245 (2%)		3/251 (1.2%)
Upper respiratory tract infection	5/260 (1.9%)		3/245 (1.2%)		0/251 (0%)
Influenza	1/260 (0.4%)		3/245 (1.2%)		3/251 (1.2%)
Urinary tract infection	2/260 (0.8%)		1/245 (0.4%)		3/251 (1.2%)
Bronchitis	3/260 (1.2%)		1/245 (0.4%)		1/251 (0.4%)
Pneumonia	0/260 (0%)		1/245 (0.4%)		3/251 (1.2%)
Injury, poisoning and procedural complications
Corneal abrasion	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Investigations
Intraocular pressure increased	0/260 (0%)		1/245 (0.4%)		1/251 (0.4%)
Coronavirus test positive	3/260 (1.2%)		4/245 (1.6%)		2/251 (0.8%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/260 (0%)		3/245 (1.2%)		0/251 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal papilloma	0/260 (0%)		0/245 (0%)		1/251 (0.4%)
Eye naevus	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Melanocytic maevus	0/260 (0%)		1/245 (0.4%)		0/251 (0%)
Nervous system disorders
Migraine with aura	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Headache	8/260 (3.1%)		7/245 (2.9%)		3/251 (1.2%)
Dysgeusia	4/260 (1.5%)		5/245 (2%)		0/251 (0%)
Migraine	3/260 (1.2%)		1/245 (0.4%)		2/251 (0.8%)
Dizziness	3/260 (1.2%)		1/245 (0.4%)		0/251 (0%)
Respiratory, thoracic and mediastinal disorders
Sneezing	247/260 (95%)		237/245 (96.7%)		73/251 (29.1%)
Cough	49/260 (18.8%)		54/245 (22%)		5/251 (2%)
Throat irritation	35/260 (13.5%)		44/245 (18%)		5/251 (2%)
Nasal congestion	10/260 (3.8%)		5/245 (2%)		12/251 (4.8%)
Nasal mucosal disorder	9/260 (3.5%)		8/245 (3.3%)		9/251 (3.6%)
Nasal discomfort	7/260 (2.7%)		6/245 (2.4%)		6/251 (2.4%)
Rhinorrhoea	7/260 (2.7%)		8/245 (3.3%)		4/251 (1.6%)
Epistaxis	9/260 (3.5%)		6/245 (2.4%)		2/251 (0.8%)
Nasal inflammation	3/260 (1.2%)		2/245 (0.8%)		2/251 (0.8%)
Nasal crusting	3/260 (1.2%)		0/245 (0%)		2/251 (0.8%)
Nasal dryness	1/260 (0.4%)		1/245 (0.4%)		3/251 (1.2%)
Upper-airway cough syndrome	1/260 (0.4%)		3/245 (1.2%)		1/251 (0.4%)
Oropharyngeal discomfort	3/260 (1.2%)		0/245 (0%)		0/251 (0%)
Skin and subcutaneous tissue disorders
Ecchymosis	1/260 (0.4%)		0/245 (0%)		0/251 (0%)
Rash	1/260 (0.4%)		3/245 (1.2%)		0/251 (0%)
Vascular disorders
Hypertension	4/260 (1.5%)		1/245 (0.4%)		1/251 (0.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.