Trial Outcomes & Findings for RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study (NCT NCT05202808)

NCT ID: NCT05202808

Last Updated: 2025-04-20

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

500 participants

Primary outcome timeframe

Postop Month 6

Results posted on

2025-04-20

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL Control IOL: Control treatment group will receive a Control IOL
Overall Study STARTED	335 335	165 165
Overall Study COMPLETED	332 332	164 164
Overall Study NOT COMPLETED	3 3	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL Control IOL: Control treatment group will receive a Control IOL
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=335 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=165 Participants Control IOL: Control treatment group will receive a Control IOL	Total n=500 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 6.9 • n=93 Participants	67.1 years STANDARD_DEVIATION 6.3 • n=4 Participants	67.1 years STANDARD_DEVIATION 6.8 • n=27 Participants
Sex: Female, Male Female	227 Participants n=93 Participants	106 Participants n=4 Participants	333 Participants n=27 Participants
Sex: Female, Male Male	108 Participants n=93 Participants	59 Participants n=4 Participants	167 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Asian	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	23 Participants n=93 Participants	8 Participants n=4 Participants	31 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	305 Participants n=93 Participants	156 Participants n=4 Participants	461 Participants n=27 Participants
Region of Enrollment United States	335 participants n=93 Participants	165 participants n=4 Participants	500 participants n=27 Participants

PRIMARY outcome

Timeframe: Postop Month 6

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=332 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=164 Participants Control IOL: Control treatment group will receive a Control IOL
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control	0.210 Diopters Standard Deviation 0.213	0.345 Diopters Standard Deviation 0.265

PRIMARY outcome

Timeframe: Postop Month 6

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=332 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=164 Participants Control IOL: Control treatment group will receive a Control IOL
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control	0.262 Diopters Standard Deviation 0.275	0.820 Diopters Standard Deviation 0.554

SECONDARY outcome

Timeframe: Postop Month 6

The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=185 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=97 Participants Control IOL: Control treatment group will receive a Control IOL
Rate of Endothelial Cell Density Loss	5.1 percentage Endothelial Cell Change Interval 3.8 to 7.0	4.9 percentage Endothelial Cell Change Interval 3.0 to 6.5

SECONDARY outcome

Timeframe: Postop Month 6

Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=331 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL Control IOL: Control treatment group will receive a Control IOL
Rate of Retinal Findings	0 Participants	—

POST_HOC outcome

Timeframe: 6 months

Success defined as UCDVA 20/20 or better, failure defined as UCDVA worse than 20/20. Odds defined as number of successes divided by number of failures.

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=332 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=164 Participants Control IOL: Control treatment group will receive a Control IOL
Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group UCDVA 20/20 or better	274 Participants	83 Participants
Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group UCDVA worse than 20/20	58 Participants	81 Participants

POST_HOC outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=332 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=164 Participants Control IOL: Control treatment group will receive a Control IOL
Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group Absolute MRCYL 0.50 D or less	307 Participants	61 Participants
Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group Absolute MCRYL worse than 0.50 D	25 Participants	103 Participants

POST_HOC outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=332 Participants Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=164 Participants Control IOL: Control treatment group will receive a Control IOL
Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group Simultaneous absolute MRSE and absolute MRCYL of 0.50 D or less	291 Participants	54 Participants
Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group Simultaneous absolute MRSE and absolute MRCYL worse than 0.50 D	41 Participants	110 Participants

Adverse Events

Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Serious events: 7 serious events

Other events: 71 other events

Deaths: 0 deaths

Control IOL

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=335 participants at risk Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=165 participants at risk Control IOL: Control treatment group will receive a Control IOL
Surgical and medical procedures Secondary Surgical Intervention: Intraocular Lens Exchange	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Surgical and medical procedures Secondary Surgical Intervention: Iris Repositioning following prolapse	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Surgical and medical procedures Secondary Surgical Intervention: Study Eye, Selective Laser Trabeculoplasty	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Surgical and medical procedures Secondary Surgical Intervention: Non-Study Eye Intraocular Lens Exchange	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Non-Study Eye, Full Thickness Macular Hole	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Surgical and medical procedures Secondary Surgical Intervention: Non-Study Eye, Macular Hole Repair	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Injury, poisoning and procedural complications Inpatient hospitalization following Hip Replacement Surgery	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Surgical and medical procedures Inpatient hospitalization for Ventral Hernia Repair Surgery	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Infections and infestations Inpatient hospitalization due to Pneumonia	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Infections and infestations Inpatient hospitalization due to Salmonella Infection	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Surgical and medical procedures Inpatient hospitalization due to Obstruction of Gallbladder	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.

Other adverse events

Additional Information

Director, Clinical Trials

RxSight, Inc.

Phone: 9494215463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n=335 participants at risk Light Adjustable lens (LAL) and Light Delivery Device (LDD): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Control IOL n=165 participants at risk Control IOL: Control treatment group will receive a Control IOL
Eye disorders Allergic Conjunctivitis	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Amaurosis Fugax	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Anterior Chamber Inflammation	1.8% 6/335 • Number of events 7 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	3.6% 6/165 • Number of events 7 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Surgical and medical procedures Blepharoplasty	0.30% 1/335 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Blurry Vision	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Clinically significant cystoid macular edema	0.60% 2/335 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	2.4% 4/165 • Number of events 4 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Conjunctival Cyst	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Corneal Abrasion	1.2% 4/335 • Number of events 4 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Cystoid Macular Edema	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders De-centered optic	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Dot Hemorrhage	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Epithelial Defect	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Hypertensive Retinopathy	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	1.2% 2/165 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Iritis	0.60% 2/335 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Keratoconjunctivitis Sicca, not specified as Sjogrens	0.60% 2/335 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Corneal Erosion	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Corneal Edema	0.60% 2/335 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Conjunctivochalasis	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Conjunctivitis Medicamentosa	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Conjunctival Hyperemia	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Visual Symptoms due to Concussion	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Dot Hemorrhages and Microaneurysms	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Dry Eye	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Dry Eye Syndrome	2.1% 7/335 • Number of events 7 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Epiretinal Membrane	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Epithelial Basement Membrane Dystrophy	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Erythropsia score 2 (red) any time after Week 3 or Erythropsia score 1 (pink) or 2 (red) at Month 6	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Floaters	0.60% 2/335 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Headache	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Hordeolum	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Light Treatment Sensitivity	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Loss of BCDVA of >= 10 letters (when compared to Preop and/or Postop Week 3 BCDVA)	0.60% 2/335 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	2.4% 4/165 • Number of events 4 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Meibomian Gland Dysfunction	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Ocular Allergies	0.60% 2/335 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Ocular Hypertension	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Posterior Capsular tear	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Posterior Vitreous Detachment	0.60% 2/335 • Number of events 3 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Raised IOP	4.2% 14/335 • Number of events 14 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	3.0% 5/165 • Number of events 5 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Raised IOP >=10 mmHg above preop & >=25 mmHg (if present > Week 1), unrelated to mech. pupil. block	0.90% 3/335 • Number of events 3 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Rebound Iritis	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Retinal Hole	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Retinal Microaneurysm	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Subconjunctival Abrasion with Hemorrhage	0.00% 0/335 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Superficial Punctate Keratitis	4.8% 16/335 • Number of events 16 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	1.2% 2/165 • Number of events 2 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Uveitis	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.61% 1/165 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.
Eye disorders Wound leak	0.30% 1/335 • Number of events 1 • 6 months Non-serious, ocular AEs are being reported for study eyes only.	0.00% 0/165 • 6 months Non-serious, ocular AEs are being reported for study eyes only.