Trial Outcomes & Findings for A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery (NCT NCT01886690)

Results Overview

The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

148 participants

Primary outcome timeframe

Day 90

Results posted on

2019-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	New Eye Drop Formulation 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Overall Study STARTED	75	73
Overall Study COMPLETED	75	71
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	New Eye Drop Formulation 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Overall Study Protocol Violation	0	1
Overall Study Personal Reasons	0	1

Baseline Characteristics

A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New Eye Drop Formulation n=75 Participants 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® n=73 Participants 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.	Total n=148 Participants Total of all reporting groups
Age, Customized < 40 years	58 Participants n=5 Participants	51 Participants n=7 Participants	109 Participants n=5 Participants
Age, Customized ≥ 40 years	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	34 Participants n=7 Participants	73 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 90

Population: Per Protocol: all randomized patients who had no significant protocol violations

The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation n=68 Participants 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® n=57 Participants 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale	6.99 Scores on a Scale Standard Deviation 8.511	6.63 Scores on a Scale Standard Deviation 7.071

SECONDARY outcome

Timeframe: Baseline, Day 90

Population: Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point

The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement) and a positive change from baseline represents an increase in corneal staining (worsening).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation n=68 Participants 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® n=58 Participants 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Change From Baseline in Corneal Staining in the Worse Eye Baseline	0.9 Scores on a Scale Standard Deviation 1.28	1.2 Scores on a Scale Standard Deviation 1.31
Change From Baseline in Corneal Staining in the Worse Eye Change from Baseline at Day 90 (N=68, 57)	0.2 Scores on a Scale Standard Deviation 1.96	-0.3 Scores on a Scale Standard Deviation 1.61

SECONDARY outcome

Timeframe: Baseline, Day 90

Population: Intent-to-Treat: all randomized patients who had data at the noted time point

TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation n=75 Participants 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® n=73 Participants 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye Baseline	11.88 Seconds Standard Deviation 11.656	9.27 Seconds Standard Deviation 5.121
Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye Change from Baseline at Day 90 (N=75, 71)	1.21 Seconds Standard Deviation 9.299	1.08 Seconds Standard Deviation 5.304

SECONDARY outcome

Timeframe: Baseline, Day 90

Population: Intent-to-Treat: all randomized patients who had data at the noted time point

The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation n=75 Participants 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® n=73 Participants 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Change From Baseline in the Schirmer Test in the Worse Eye Baseline	13.1 Millimeters in 5 minutes (mm/5 min) Standard Deviation 9.10	13.0 Millimeters in 5 minutes (mm/5 min) Standard Deviation 8.74
Change From Baseline in the Schirmer Test in the Worse Eye Change from Baseline at Day 90 (N=75, 71)	1.4 Millimeters in 5 minutes (mm/5 min) Standard Deviation 8.55	1.3 Millimeters in 5 minutes (mm/5 min) Standard Deviation 9.89

SECONDARY outcome

Timeframe: Baseline, Day 90

Population: Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point

Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.

Outcome measures

Outcome measures
Measure	New Eye Drop Formulation n=68 Participants 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® n=58 Participants 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Change From Baseline in Uncorrected Visual Acuity in the Worse Eye Baseline	51.1 Letters Read Correctly Standard Deviation 10.00	53.1 Letters Read Correctly Standard Deviation 9.49
Change From Baseline in Uncorrected Visual Acuity in the Worse Eye Change from Baseline at Day 90 (N=68, 57)	5.8 Letters Read Correctly Standard Deviation 5.24	4.7 Letters Read Correctly Standard Deviation 6.02

Adverse Events

New Eye Drop Formulation

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

REFRESH PLUS®

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	New Eye Drop Formulation n=75 participants at risk 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® n=73 participants at risk 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Gastrointestinal disorders Abdominal Pain	0.00% 0/75 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	1.4% 1/73 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).

Other adverse events

Other adverse events
Measure	New Eye Drop Formulation n=75 participants at risk 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.	REFRESH PLUS® n=73 participants at risk 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
Infections and infestations Nasopharyngitis	2.7% 2/75 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	5.5% 4/73 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Nervous system disorders Headache	1.3% 1/75 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	11.0% 8/73 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Blepharitis	1.3% 1/75 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	8.2% 6/73 The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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