A Phase 3 interventional study of Refresh Optive® Gel Drops and REFRESH LIQUIGEL® in Dry Eye Syndromes, sponsored by Allergan. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 188 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Drug: Refresh Optive® Gel Drops
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Drug: REFRESH LIQUIGEL®
Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Time frame: Baseline, Day 30
Change From Baseline in the OSDI© Score
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Time frame: Baseline, Day 7
Change From Baseline in Tear Break-up Time (TBUT)
TBUT is the time required for dry spots to appear on the surface of the eye after blinking. 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). The eye with shorter average TBUT at baseline is reported for each patient.
Time frame: Baseline, Day 30
Change From Baseline in the Combined Corneal and Conjunctival Staining Scores
The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.
Time frame: Baseline, Day 30
Change From Baseline in the Schirmer Test
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.
Time frame: Baseline, Day 30
| Milestone | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® |
|---|---|---|
| Started | 94 | 94 |
| Completed | 93 | 91 |
| Not completed | 1 | 3 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
| Scores on a Scale | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® |
|---|---|---|
| Baseline | 42.44 ± 11.708 | 40.43 ± 11.232 |
| Change from Baseline at Day 30 | -10.29 ± 15.864 | -7.48 ± 16.592 |
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
| Scores on a Scale | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® |
|---|---|---|
| Baseline | 42.44 ± 11.708 | 40.43 ± 11.232 |
| Change from Baseline at Day 7 | -5.74 ± 14.338 | -2.34 ± 12.294 |
TBUT is the time required for dry spots to appear on the surface of the eye after blinking. 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). The eye with shorter average TBUT at baseline is reported for each patient.
| Seconds | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® |
|---|---|---|
| Baseline | 5.38 ± 1.674 | 5.40 ± 2.138 |
| Change from Baseline at Day 30 (N-94, 93) | 0.84 ± 1.968 | 0.70 ± 4.139 |
The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.
| Scores on a Scale | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® |
|---|---|---|
| Baseline | 10.9 ± 7.24 | 11.8 ± 7.16 |
| Change from Baseline at Day 30 (N=93, 91) | -1.7 ± 4.66 | -2.0 ± 6.12 |
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.
| mm/5 min | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® |
|---|---|---|
| Baseline | 9.98 ± 7.178 | 11.32 ± 8.496 |
| Change from Baseline at Day 30 (N=88, 86) | 0.89 ± 5.601 | 0.69 ± 6.479 |
Collected over Adverse events were recorded from Screening through Day 30.. Non-serious events are listed at a 5.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Refresh Optive® Gel Drops | — | 0/94 (0%) | 7/94 (7.4%) |
| REFRESH LIQUIGEL® | — | 1/94 (1.1%) | 5/94 (5.3%) |
| Event | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® |
|---|---|---|
| HyphaemaEye disorders | 0/94 | 1/94 |
| Event | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® |
|---|---|---|
| Vision blurredEye disorders | 7/94 | 5/94 |
All 188 randomized patients were included in the Intent-to Treat (ITT) and safety populations.
| Age, Customized(Participants) | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® | Total |
|---|---|---|---|
| 18 to less than 30 years | 11 | 13 | 24 |
| 30 to 40 years | 11 | 14 | 25 |
| More than 40 years | 72 | 67 | 139 |
| Sex: Female, Male(Participants) | Refresh Optive® Gel Drops | REFRESH LIQUIGEL® | Total |
|---|---|---|---|
| Female | 78 | 75 | 153 |
| Male | 16 | 19 | 35 |
Plan to share: No
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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