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

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ClinicalTrials.gov Identifier: NCT03636061
Recruitment Status : Completed
First Posted : August 17, 2018
Results First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Oyster Point Pharma, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye Disease
Interventions Drug: OC-01 (varenicline) nasal spray
Drug: Placebo (vehicle) nasal spray
Enrollment 182
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OC-01 Low Dose, 0.12 mg/ml OC-01 Mid Dose, 0.6 mg/ml OC-01 High Dose, 1.2 mg/ml Placebo
Hide Arm/Group Description OC-01 0.12 mg/ml nasal spray BID for 28 days OC-01 0.6 mg/ml nasal spray BID for 28 days OC-01 1.2 mg/ml nasal spray BID for 28 days Placebo (vehicle) nasal spray
Period Title: Overall Study
Started 47 48 44 43
Completed 47 46 40 43
Not Completed 0 2 4 0
Arm/Group Title OC-01 Low Dose, 0.12 mg/mL OC-01 Mid Dose, 0.6 mg/mL OC-01 High Dose, 1.2 mg/mL Placebo Total
Hide Arm/Group Description OC-01 0.12 mg/ml nasal spray BID for 28 days OC-01 0.6 mg/ml nasal spray BID for 28 days OC-01 1.2 mg/ml nasal spray BID for 28 days Vehicle nasal spray Total of all reporting groups
Overall Number of Baseline Participants 47 48 44 43 182
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 48 participants 44 participants 43 participants 182 participants
64.2  (12.7) 66.5  (9.4) 67.4  (10.6) 64  (10.3) 65.5  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 44 participants 43 participants 182 participants
Female
36
  76.6%
34
  70.8%
35
  79.5%
32
  74.4%
137
  75.3%
Male
11
  23.4%
14
  29.2%
9
  20.5%
11
  25.6%
45
  24.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 44 participants 43 participants 182 participants
Hispanic or Latino
8
  17.0%
3
   6.3%
2
   4.5%
5
  11.6%
18
   9.9%
Not Hispanic or Latino
39
  83.0%
45
  93.8%
42
  95.5%
38
  88.4%
164
  90.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 44 participants 43 participants 182 participants
American Indian or Alaska Native 0 1 1 0 2
Asian 3 4 0 1 8
Native Hawaiian or Other Pacific Islander 0 0 1 0 1
Black or African American 2 4 6 2 14
White 42 39 36 40 157
More than one race 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 48 participants 44 participants 43 participants 182 participants
47 48 44 43 182
Schirmer's Test Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 47 participants 48 participants 44 participants 43 participants 182 participants
5.2  (3.1) 4.8  (2.7) 5.5  (3.0) 4.5  (2.9) 5.0  (2.9)
[1]
Measure Description: Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.
1.Primary Outcome
Title Mean Change in Schirmer's Test Score From Baseline to 28 Days
Hide Description The primary end point was the change in anesthetized Schirmer's Test Score (STS) from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.
Time Frame 28 Days [Visit 1 (baseline) and Visit 5 (28 days)]
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in ITT-LOCF population
Arm/Group Title OC-01 Low Dose, 0.12 mg/mL OC-01 Mid Dose, 0.6 mg/ML OC-01 High Dose, 1.2 mg/mL Placebo
Hide Arm/Group Description:
OC-01 0.12 mg/ml nasal spray
OC-01 0.6 mg/ml nasal spray
OC-01 1.2 mg/ml nasal spray
Vehicle nasal spray
Overall Number of Participants Analyzed 47 46 40 43
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale, mm
10.1  (1.26) 11.7  (1.27) 11.0  (1.39) 3.2  (1.31)
2.Secondary Outcome
Title Change From Baseline in Eye Dryness Score From Baseline to Day 28
Hide Description Change in Eye Dryness Score from baseline to 28 days. Eye Dryness (EDS) on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.
Time Frame 28 days [Visit 1 (baseline and Visit 5 (28 days)]
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT-LOCF population. The overall number of participants is different because these outcomes were assessed ar different visits 7 days apart and some subjects were not able to attend the Day 21 visit.
Arm/Group Title OC-01 Low Dose, 0.12 mg/ml OC-01 Mid Dose, 0.6 mg/ml OC-01 High Dose, 1.2 mg/ml Placebo
Hide Arm/Group Description:
OC-01 0.12 mg/ml nasal spray
OC-01 0.6 mg/ml nasal spray
OC-01 1.2 mg/ml nasal spray
Vehicle nasal spray
Overall Number of Participants Analyzed 47 46 40 43
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale, mm
-11.6  (3.63) -18.9  (3.67) -15.6  (4.02) -5.4  (3.8)
3.Secondary Outcome
Title Change From Baseline to Day 21 in Eye Dryness Score at 5 Minutes Post Treatment in the CAE.
Hide Description Change from baseline to Day 21 in Eye Dryness Score at 5 minutes post treatment in the CAE. Eye Dryness (EDS) on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.
Time Frame 21 days [Visit 1 (baseline) and Visit 4 (21 days)]
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the ITT population
Arm/Group Title OC-01 Low Dose, 0.12 mg/ml OC-01 Mid Dose, 0.6 mg/ml OC-01 High Dose, 1.2 mg/ml Placebo
Hide Arm/Group Description:
OC-01 0.12 mg/ml nasal spray
OC-01 0.6 mg/ml nasal spray
OC-01 1.2 mg/ml nasal spray
Vehicle nasal spray
Overall Number of Participants Analyzed 44 45 38 42
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale, mm
-8.1  (2.7) -16.0  (2.7) -18.4  (3.0) -4.4  (2.8)
Time Frame Adverse Events were collected from the first dose of study drug administration until the final study visit at Visit 5 (28 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OC-01 Low Dose, 0.12 mg/mL OC-01 Mid Dose, 0.6 mg/mL OC-01 High Dose, 1.2 mg/mL Placebo
Hide Arm/Group Description OC-01 0.12 mg/ml nasal spray OC-01 0.6 mg/ml nasal spray OC-01 1.2 mg/ml nasal spray Vehicle nasal spray
All-Cause Mortality
OC-01 Low Dose, 0.12 mg/mL OC-01 Mid Dose, 0.6 mg/mL OC-01 High Dose, 1.2 mg/mL Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)      0/48 (0.00%)      0/44 (0.00%)      0/43 (0.00%)    
Hide Serious Adverse Events
OC-01 Low Dose, 0.12 mg/mL OC-01 Mid 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 Affected / at Risk (%) # Events
Total   0/47 (0.00%)      1/48 (2.08%)      0/44 (0.00%)      0/43 (0.00%)    
Blood and lymphatic system disorders         
Anaemia  1  0/47 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
OC-01 Low Dose, 0.12 mg/mL OC-01 Mid 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 Affected / at Risk (%) # Events
Total   33/47 (70.21%)      44/48 (91.67%)      41/44 (93.18%)      11/43 (25.58%)    
Eye disorders         
Ocular TEAEs  1  1/47 (2.13%)  1 2/48 (4.17%)  2 1/44 (2.27%)  1 7/43 (16.28%)  7
Visual acuity reduced  1  1/47 (2.13%)  1 1/48 (2.08%)  1 0/44 (0.00%)  0 3/43 (6.98%)  3
Blepharospasm  1  0/47 (0.00%)  0 0/48 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Conjunctival deposit  1  0/47 (0.00%)  0 0/48 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Conjunctival haemorrhage  1  0/47 (0.00%)  0 1/48 (2.08%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Eyelid oedema  1  0/47 (0.00%)  0 0/48 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Visual impairement  1  0/47 (0.00%)  0 0/48 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Hordeolum  1  0/47 (0.00%)  0 0/48 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
General disorders         
Instillation site irritation  1  3/47 (6.38%)  3 8/48 (16.67%)  8 8/44 (18.18%)  8 0/43 (0.00%)  0
Nervous system disorders         
Headache  1  0/47 (0.00%)  0 0/48 (0.00%)  0 2/44 (4.55%)  2 1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders         
Sneezing  1  29/47 (61.70%)  29 38/48 (79.17%)  38 37/44 (84.09%)  37 0/43 (0.00%)  0
Cough  1  4/47 (8.51%)  4 6/48 (12.50%)  6 11/44 (25.00%)  11 0/43 (0.00%)  0
Throat irritation  1  0/47 (0.00%)  0 7/48 (14.58%)  7 9/44 (20.45%)  9 0/43 (0.00%)  0
Dysaesthesia pharynx  1  5/47 (10.64%)  5 4/48 (8.33%)  4 3/44 (6.82%)  3 0/43 (0.00%)  0
Nasal dryness  1  1/47 (2.13%)  1 0/48 (0.00%)  0 0/44 (0.00%)  0 2/43 (4.65%)  2
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Nau
Organization: Oyster Point Pharma, Inc.
Phone: 609-382-9035
EMail: jnau@oysterpointrx.com
Layout table for additonal information
Responsible Party: Oyster Point Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03636061    
Other Study ID Numbers: OPP-002
First Submitted: August 15, 2018
First Posted: August 17, 2018
Results First Submitted: August 13, 2021
Results First Posted: October 25, 2021
Last Update Posted: October 25, 2021