Trial Outcomes & Findings for Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects (NCT NCT04324359)

Last Updated: 2025-01-15

Results Overview

The Investigator used a slit lamp biomicroscope to assess ACCs in the study (surgery) eye. ACC counts were graded as follows: ACC Grade 0 = 0 cells were seen ACC Grade higher than 0 = 1 or more cells were seen

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

91 participants

Primary outcome timeframe

Day 15

Results posted on

2025-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	SURF-201 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Overall Study STARTED	40	43
Overall Study COMPLETED	39	41
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SURF-201 n=39 Participants 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=43 Participants Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.	Total n=82 Participants Total of all reporting groups
Age, Continuous	68.3 Years STANDARD_DEVIATION 6.82 • n=5 Participants	68.4 Years STANDARD_DEVIATION 9.90 • n=7 Participants	68.4 Years STANDARD_DEVIATION 8.53 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Anterior Chamber Cell (ACC) Grade at Baseline	39 Participants n=5 Participants	43 Participants n=7 Participants	82 Participants n=5 Participants
Ocular Pain Score at Baseline	39 Participants n=5 Participants	43 Participants n=7 Participants	82 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Randomized participants who had uncomplicated cataract surgery. Missing values were imputed using last observation carried forward (LOCF). LOCF is a common statistical approach to the analysis of longitudinal repeated measures where some follow-up (FU) observations may be missing. In a LOCF analysis, a missing FU value is replaced by (imputed as) that participant's previously observed value. The combination of the observed and imputed data is then analyzed as if there were no missing data.

Outcome measures

Outcome measures
Measure	SURF-201 n=39 Participants 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=43 Participants Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Anterior Chamber Cell (ACC) Grade: Number of Participants Achieving an ACC Grade of 0	22 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 1

Population: Randomized participants who underwent routine uncomplicated cataract surgery and had no missing assessments.

Ocular pain was assessed and graded by the participants using the Visual Analog Scale (VAS). The VAS was scored from 0 to 100 using a mark on the 100 mm line (0=absent \[no pain\], 100=maximum \[severe pain\]).

Outcome measures

Outcome measures
Measure	SURF-201 n=39 Participants 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=43 Participants Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0	27 Participants	21 Participants

SECONDARY outcome

Timeframe: Day 8

Population: Randomized participants who underwent routine uncomplicated cataract surgery and had no missing assessments.

Outcome measures

Outcome measures
Measure	SURF-201 n=39 Participants 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=41 Participants Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0	32 Participants	32 Participants

SECONDARY outcome

Timeframe: Day 15

Population: Randomized participants who underwent routine uncomplicated cataract surgery and had no missing assessments.

Outcome measures

Outcome measures
Measure	SURF-201 n=39 Participants 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=40 Participants Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0	35 Participants	33 Participants

SECONDARY outcome

Timeframe: Day 22

Outcome measures

Outcome measures
Measure	SURF-201 n=39 Participants 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=40 Participants Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0	35 Participants	37 Participants

SECONDARY outcome

Timeframe: Day 32

Population: Randomized participants who underwent routine uncomplicated cataract surgery and had no missing VAS assessments.

Outcome measures

Outcome measures
Measure	SURF-201 n=38 Participants 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=41 Participants Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Post-surgical Ocular Pain Score: Number of Participants Achieving an Ocular Pain Score of 0	35 Participants	39 Participants

Adverse Events

SURF-201

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SURF-201 n=40 participants at risk 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=43 participants at risk Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Eye disorders Cystoid macular edema	2.5% 1/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	0.00% 0/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Posterior caple rupture	2.5% 1/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	0.00% 0/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Investigations Intraocular pressure increased	5.0% 2/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	0.00% 0/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.

Other adverse events

Other adverse events
Measure	SURF-201 n=40 participants at risk 0.2% topical preservative-free corticosteroid solution (0.2% betamethasone sodium phosphate) SURF-201: One drop twice daily (BID) in the study eye for 16 days.	Vehicle n=43 participants at risk Topical preservative-free vehicle (Placebo) Placebo: One drop twice daily (BID) in the study eye for 16 days.
Eye disorders Visual acuity reduced	15.0% 6/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	23.3% 10/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Eye inflammation	15.0% 6/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	18.6% 8/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Posterior capsule opacification	12.5% 5/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	14.0% 6/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Eye pain	12.5% 5/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	9.3% 4/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Corneal edema	5.0% 2/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	9.3% 4/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Photophobia	5.0% 2/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	7.0% 3/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Conjunctival hyperemia	2.5% 1/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	7.0% 3/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Iritis	7.5% 3/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	2.3% 1/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Vitreous detachment	7.5% 3/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	2.3% 1/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Eye irritation	7.5% 3/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	0.00% 0/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Eye disorders Vitreous floaters	5.0% 2/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	2.3% 1/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.
Investigations Intraocular pressure increased	10.0% 4/40 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.	2.3% 1/43 • Overall study period Adverse events were collected from each participant's signature of informed consent at Screening through Day 32 (completion of the study) or early withdrawal.

Additional Information

VP, Clinical Operations

Surface Ophthalmics Inc.

Phone: (925) 494-3660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place